Details for New Drug Application (NDA): 018692
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NDA 018692 describes MARCAINE, which is a drug marketed by Hospira and is included in two NDAs. It is available from one supplier. Additional details are available on the MARCAINE profile page.
The generic ingredient in MARCAINE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
The generic ingredient in MARCAINE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 018692
| Tradename: | MARCAINE |
| Applicant: | Hospira |
| Ingredient: | bupivacaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 018692
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 018692
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MARCAINE | bupivacaine hydrochloride | INJECTABLE;SPINAL | 018692 | NDA | Hospira, Inc. | 0409-1761 | 0409-1761-10 | 2 CELLO PACK in 1 CARTON (0409-1761-10) / 5 AMPULE in 1 CELLO PACK (0409-1761-05) / 2 mL in 1 AMPULE (0409-1761-18) |
| MARCAINE | bupivacaine hydrochloride | INJECTABLE;SPINAL | 018692 | NDA | Hospira, Inc. | 0409-1761 | 0409-1761-62 | 800 AMPULE in 1 CASE (0409-1761-62) / 2 mL in 1 AMPULE (0409-1761-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SPINAL | Strength | 0.75% | ||||
| Approval Date: | May 4, 1984 | TE: | AP | RLD: | Yes | ||||
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