List of Excipients in API BACLOFEN
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Excipients in NDA-approved (novel) drugs containing BACLOFEN
| Company | Tradename | Ingredient | NDC | Excipient | Potential Generic Entry |
|---|---|---|---|---|---|
| Wilshire Pharmaceuticals Inc | BACLOFEN | baclofen | 52536-600 | ANHYDROUS CITRIC ACID | |
| Wilshire Pharmaceuticals Inc | BACLOFEN | baclofen | 52536-600 | D&C YELLOW NO. 10 | |
| Wilshire Pharmaceuticals Inc | BACLOFEN | baclofen | 52536-600 | DIMETHICONE | |
| Wilshire Pharmaceuticals Inc | BACLOFEN | baclofen | 52536-600 | FD&C RED NO. 40 | |
| Wilshire Pharmaceuticals Inc | BACLOFEN | baclofen | 52536-600 | HYDROXYETHYL CELLULOSE | |
| Wilshire Pharmaceuticals Inc | BACLOFEN | baclofen | 52536-600 | PROPYLENE GLYCOL | |
| Wilshire Pharmaceuticals Inc | BACLOFEN | baclofen | 52536-600 | SILICON DIOXIDE | |
| >Company | >Tradename | >Ingredient | >NDC | >Excipient | >Potential Generic Entry |
Excipients in ANDA-approved (generic) drugs containing BACLOFEN
Detailed excipient profiles for BACLOFEN
Excipient focus: ANHYDROUS CITRIC ACID
BACLOFEN drug variants containing ANHYDROUS CITRIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| Wilshire Pharmaceuticals Inc | baclofen | 52536-600 |
| Azurity Pharmaceuticals Inc | baclofen | 52652-6001 |
| Palmetto Pharmaceuticals Inc | baclofen | 68134-401 |
| Metacel Pharmaceuticals LLC | baclofen | 69528-301 |
| Bryant Ranch Prepack | baclofen | 72162-2342 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing ANHYDROUS CITRIC ACID
Excipient focus: ANHYDROUS DIBASIC CALCIUM PHOSPHATE
BACLOFEN drug variants containing ANHYDROUS DIBASIC CALCIUM PHOSPHATE
| Company | Ingredient | NDC |
|---|---|---|
| A-S Medication Solutions | baclofen | 50090-4682 |
| A-S Medication Solutions | baclofen | 50090-6149 |
| American Health Packaging | baclofen | 60687-804 |
| Preferred Pharmaceuticals Inc | baclofen | 68788-7551 |
| Preferred Pharmaceuticals Inc | baclofen | 68788-7562 |
| Bryant Ranch Prepack | baclofen | 71335-1356 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Excipient focus: ANHYDROUS LACTOSE
BACLOFEN drug variants containing ANHYDROUS LACTOSE
BACLOFEN drug variants not containing ANHYDROUS LACTOSE
Excipient focus: CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
BACLOFEN drug variants containing CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
| Company | Ingredient | NDC |
|---|---|---|
| AvPAK | baclofen | 50268-105 |
| AvPAK | baclofen | 50268-106 |
| Zydus Pharmaceuticals (USA) Inc | baclofen | 70710-1285 |
| Zydus Lifesciences Limited | baclofen | 70771-1448 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
Excipient focus: CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
BACLOFEN drug variants containing CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
BACLOFEN drug variants not containing CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
Excipient focus: CALCIUM STEARATE
BACLOFEN drug variants containing CALCIUM STEARATE
| Company | Ingredient | NDC |
|---|---|---|
| Amneal Pharmaceuticals LLC | baclofen | 64896-076 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing CALCIUM STEARATE
Excipient focus: CELLULOSE, MICROCRYSTALLINE
BACLOFEN drug variants containing CELLULOSE, MICROCRYSTALLINE
BACLOFEN drug variants not containing CELLULOSE, MICROCRYSTALLINE
Excipient focus: COLLOIDAL SILICON DIOXIDE
BACLOFEN drug variants containing COLLOIDAL SILICON DIOXIDE
| Company | Ingredient | NDC |
|---|---|---|
| HJ Harkins Company Inc | baclofen | 52959-733 |
| State of Florida DOH Central Pharmacy | baclofen | 53808-1036 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing COLLOIDAL SILICON DIOXIDE
Excipient focus: CROSCARMELLOSE SODIUM
BACLOFEN drug variants containing CROSCARMELLOSE SODIUM
BACLOFEN drug variants not containing CROSCARMELLOSE SODIUM
Excipient focus: CROSPOVIDONE
BACLOFEN drug variants containing CROSPOVIDONE
BACLOFEN drug variants not containing CROSPOVIDONE
Excipient focus: D&C YELLOW NO. 10
BACLOFEN drug variants containing D&C YELLOW NO. 10
| Company | Ingredient | NDC |
|---|---|---|
| Wilshire Pharmaceuticals Inc | baclofen | 52536-600 |
| Azurity Pharmaceuticals Inc | baclofen | 52652-6001 |
| Bryant Ranch Prepack | baclofen | 72162-2342 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing D&C YELLOW NO. 10
Excipient focus: DIBASIC CALCIUM PHOSPHATE DIHYDRATE
BACLOFEN drug variants containing DIBASIC CALCIUM PHOSPHATE DIHYDRATE
BACLOFEN drug variants not containing DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Excipient focus: DIMETHICONE
BACLOFEN drug variants containing DIMETHICONE
| Company | Ingredient | NDC |
|---|---|---|
| Wilshire Pharmaceuticals Inc | baclofen | 52536-600 |
| Azurity Pharmaceuticals Inc | baclofen | 52652-6001 |
| ANI Pharmaceuticals Inc | baclofen | 62559-204 |
| Slayback Pharma LLC | baclofen | 71225-140 |
| Bryant Ranch Prepack | baclofen | 72162-2342 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing DIMETHICONE
Excipient focus: DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER
BACLOFEN drug variants containing DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER
| Company | Ingredient | NDC |
|---|---|---|
| Amneal Pharmaceuticals LLC | baclofen | 64896-076 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER
Excipient focus: FD&C RED NO. 40
BACLOFEN drug variants containing FD&C RED NO. 40
| Company | Ingredient | NDC |
|---|---|---|
| Wilshire Pharmaceuticals Inc | baclofen | 52536-600 |
| Azurity Pharmaceuticals Inc | baclofen | 52652-6001 |
| Bryant Ranch Prepack | baclofen | 72162-2342 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing FD&C RED NO. 40
Excipient focus: GLYCERIN
BACLOFEN drug variants containing GLYCERIN
| Company | Ingredient | NDC |
|---|---|---|
| TRUPHARMA LLC | baclofen | 52817-620 |
| Palmetto Pharmaceuticals Inc | baclofen | 68134-401 |
| Metacel Pharmaceuticals LLC | baclofen | 69528-301 |
| Metacel Pharmaceuticals LLC | baclofen | 69528-302 |
| Sarras Health LLC | baclofen | 72834-602 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing GLYCERIN
Excipient focus: HYDROCHLORIC ACID
BACLOFEN drug variants containing HYDROCHLORIC ACID
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | baclofen | 62559-204 |
| Slayback Pharma LLC | baclofen | 71225-140 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing HYDROCHLORIC ACID
Excipient focus: HYDROXYETHYL CELLULOSE
BACLOFEN drug variants containing HYDROXYETHYL CELLULOSE
| Company | Ingredient | NDC |
|---|---|---|
| Wilshire Pharmaceuticals Inc | baclofen | 52536-600 |
| Azurity Pharmaceuticals Inc | baclofen | 52652-6001 |
| Bryant Ranch Prepack | baclofen | 72162-2342 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing HYDROXYETHYL CELLULOSE
Excipient focus: HYPROMELLOSE
BACLOFEN drug variants containing HYPROMELLOSE
BACLOFEN drug variants not containing HYPROMELLOSE
Excipient focus: HYPROMELLOSE 2910
BACLOFEN drug variants containing HYPROMELLOSE 2910
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | baclofen | 62559-204 |
| Slayback Pharma LLC | baclofen | 71225-140 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing HYPROMELLOSE 2910
Excipient focus: HYPROMELLOSES
BACLOFEN drug variants containing HYPROMELLOSES
| Company | Ingredient | NDC |
|---|---|---|
| Amneal Pharmaceuticals LLC | baclofen | 64896-076 |
| Eywa Pharma Inc | baclofen | 71930-066 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing HYPROMELLOSES
Excipient focus: LACTOSE MONOHYDRATE
BACLOFEN drug variants containing LACTOSE MONOHYDRATE
BACLOFEN drug variants not containing LACTOSE MONOHYDRATE
Excipient focus: MAGNESIUM STEARATE
BACLOFEN drug variants containing MAGNESIUM STEARATE
BACLOFEN drug variants not containing MAGNESIUM STEARATE
Excipient focus: MANNITOL
BACLOFEN drug variants containing MANNITOL
BACLOFEN drug variants not containing MANNITOL
Excipient focus: METHYLPARABEN
BACLOFEN drug variants containing METHYLPARABEN
| Company | Ingredient | NDC |
|---|---|---|
| TRUPHARMA LLC | baclofen | 52817-620 |
| ANI Pharmaceuticals Inc | baclofen | 62559-204 |
| Palmetto Pharmaceuticals Inc | baclofen | 68134-401 |
| Metacel Pharmaceuticals LLC | baclofen | 69528-301 |
| Metacel Pharmaceuticals LLC | baclofen | 69528-302 |
| Slayback Pharma LLC | baclofen | 71225-140 |
| Sarras Health LLC | baclofen | 72834-602 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing METHYLPARABEN
Excipient focus: MICROCRYSTALLINE CELLULOSE 112
BACLOFEN drug variants containing MICROCRYSTALLINE CELLULOSE 112
BACLOFEN drug variants not containing MICROCRYSTALLINE CELLULOSE 112
Excipient focus: NITROGEN
BACLOFEN drug variants containing NITROGEN
| Company | Ingredient | NDC |
|---|---|---|
| Sagent Pharmaceuticals | baclofen | 25021-678 |
| Sagent Pharmaceuticals | baclofen | 25021-680 |
| Sagent Pharmaceuticals | baclofen | 25021-681 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing NITROGEN
Excipient focus: POVIDONE
BACLOFEN drug variants containing POVIDONE
BACLOFEN drug variants not containing POVIDONE
Excipient focus: POVIDONE K30
BACLOFEN drug variants containing POVIDONE K30
| Company | Ingredient | NDC |
|---|---|---|
| Rising Pharma Holdings Inc | baclofen | 16571-169 |
| Northstar RxLLC | baclofen | 16714-071 |
| Medsource Pharmaceuticals | baclofen | 45865-275 |
| A-S Medication Solutions | baclofen | 50090-4682 |
| A-S Medication Solutions | baclofen | 50090-6149 |
| AvPAK | baclofen | 50268-105 |
| AvPAK | baclofen | 50268-106 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing POVIDONE K30
Excipient focus: POVIDONES
BACLOFEN drug variants containing POVIDONES
| Company | Ingredient | NDC |
|---|---|---|
| Atlantic Biologicals Corps | baclofen | 17856-1024 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing POVIDONES
Excipient focus: PROPYLENE GLYCOL
BACLOFEN drug variants containing PROPYLENE GLYCOL
| Company | Ingredient | NDC |
|---|---|---|
| Wilshire Pharmaceuticals Inc | baclofen | 52536-600 |
| Azurity Pharmaceuticals Inc | baclofen | 52652-6001 |
| Bryant Ranch Prepack | baclofen | 72162-2342 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing PROPYLENE GLYCOL
Excipient focus: PROPYLPARABEN
BACLOFEN drug variants containing PROPYLPARABEN
| Company | Ingredient | NDC |
|---|---|---|
| TRUPHARMA LLC | baclofen | 52817-620 |
| ANI Pharmaceuticals Inc | baclofen | 62559-204 |
| Palmetto Pharmaceuticals Inc | baclofen | 68134-401 |
| Metacel Pharmaceuticals LLC | baclofen | 69528-301 |
| Metacel Pharmaceuticals LLC | baclofen | 69528-302 |
| Slayback Pharma LLC | baclofen | 71225-140 |
| Sarras Health LLC | baclofen | 72834-602 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing PROPYLPARABEN
Excipient focus: SACCHARIN SODIUM
BACLOFEN drug variants containing SACCHARIN SODIUM
| Company | Ingredient | NDC |
|---|---|---|
| Amneal Pharmaceuticals LLC | baclofen | 64896-076 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing SACCHARIN SODIUM
Excipient focus: SILICON DIOXIDE
BACLOFEN drug variants containing SILICON DIOXIDE
BACLOFEN drug variants not containing SILICON DIOXIDE
Excipient focus: SODIUM BENZOATE
BACLOFEN drug variants containing SODIUM BENZOATE
| Company | Ingredient | NDC |
|---|---|---|
| Wilshire Pharmaceuticals Inc | baclofen | 52536-600 |
| Azurity Pharmaceuticals Inc | baclofen | 52652-6001 |
| Bryant Ranch Prepack | baclofen | 72162-2342 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing SODIUM BENZOATE
Excipient focus: SODIUM CHLORIDE
BACLOFEN drug variants containing SODIUM CHLORIDE
BACLOFEN drug variants not containing SODIUM CHLORIDE
Excipient focus: SODIUM HYDROXIDE
BACLOFEN drug variants containing SODIUM HYDROXIDE
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | baclofen | 62559-204 |
| Slayback Pharma LLC | baclofen | 71225-140 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing SODIUM HYDROXIDE
Excipient focus: SODIUM STARCH GLYCOLATE TYPE A
BACLOFEN drug variants containing SODIUM STARCH GLYCOLATE TYPE A
| Company | Ingredient | NDC |
|---|---|---|
| NuCare PharmaceuticalsInc | baclofen | 68071-3468 |
| Preferred Pharmaceuticals Inc | baclofen | 68788-8572 |
| REMEDYREPACK INC | baclofen | 70518-3788 |
| Lifestar Pharma LLC | baclofen | 70756-085 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing SODIUM STARCH GLYCOLATE TYPE A
Excipient focus: SODIUM STARCH GLYCOLATE TYPE A CORN
BACLOFEN drug variants containing SODIUM STARCH GLYCOLATE TYPE A CORN
| Company | Ingredient | NDC |
|---|---|---|
| Amneal Pharmaceuticals of New York LLC | baclofen | 0115-1010 |
| NCS HealthCare of KY LLC dba Vangard Labs | baclofen | 0615-8411 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing SODIUM STARCH GLYCOLATE TYPE A CORN
Excipient focus: SODIUM STARCH GLYCOLATE TYPE A POTATO
BACLOFEN drug variants containing SODIUM STARCH GLYCOLATE TYPE A POTATO
BACLOFEN drug variants not containing SODIUM STARCH GLYCOLATE TYPE A POTATO
Excipient focus: STARCH, CORN
BACLOFEN drug variants containing STARCH, CORN
BACLOFEN drug variants not containing STARCH, CORN
Excipient focus: STARCH, POTATO
BACLOFEN drug variants containing STARCH, POTATO
| Company | Ingredient | NDC |
|---|---|---|
| Northstar RxLLC | baclofen | 16714-071 |
| Mckesson Corporation DBA SKY Packaginng | baclofen | 63739-479 |
| Proficient Rx LP | baclofen | 71205-474 |
| Bryant Ranch Prepack | baclofen | 71335-0206 |
| Aphena Pharma Solutions - Tennessee LLC | baclofen | 71610-446 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing STARCH, POTATO
Excipient focus: SUCRALOSE
BACLOFEN drug variants containing SUCRALOSE
BACLOFEN drug variants not containing SUCRALOSE
Excipient focus: TALC
BACLOFEN drug variants containing TALC
| Company | Ingredient | NDC |
|---|---|---|
| Amneal Pharmaceuticals LLC | baclofen | 64896-076 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing TALC
Excipient focus: TRISODIUM CITRATE DIHYDRATE
BACLOFEN drug variants containing TRISODIUM CITRATE DIHYDRATE
| Company | Ingredient | NDC |
|---|---|---|
| Palmetto Pharmaceuticals Inc | baclofen | 68134-401 |
| Metacel Pharmaceuticals LLC | baclofen | 69528-301 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing TRISODIUM CITRATE DIHYDRATE
Excipient focus: WATER
BACLOFEN drug variants containing WATER
BACLOFEN drug variants not containing WATER
Excipient focus: XANTHAN GUM
BACLOFEN drug variants containing XANTHAN GUM
| Company | Ingredient | NDC |
|---|---|---|
| ANI Pharmaceuticals Inc | baclofen | 62559-204 |
| Slayback Pharma LLC | baclofen | 71225-140 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing XANTHAN GUM
Excipient focus: XYLITOL
BACLOFEN drug variants containing XYLITOL
| Company | Ingredient | NDC |
|---|---|---|
| Amneal Pharmaceuticals LLC | baclofen | 64896-076 |
| >Company | >Ingredient | >NDC |
BACLOFEN drug variants not containing XYLITOL
Excipient focus: ZINC STEARATE
BACLOFEN drug variants containing ZINC STEARATE
BACLOFEN drug variants not containing ZINC STEARATE
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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