Details for New Drug Application (NDA): 021171
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NDA 021171 describes DEMEROL, which is a drug marketed by Hospira and Quagen and is included in two NDAs. It is available from two suppliers. Additional details are available on the DEMEROL profile page.
The generic ingredient in DEMEROL is meperidine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.
The generic ingredient in DEMEROL is meperidine hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the meperidine hydrochloride profile page.
Summary for 021171
| Tradename: | DEMEROL |
| Applicant: | Hospira |
| Ingredient: | meperidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 021171
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 021171
Suppliers and Packaging for NDA: 021171
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEMEROL | meperidine hydrochloride | INJECTABLE;INJECTION | 021171 | NDA | Hospira, Inc. | 0409-1176 | 0409-1176-30 | 10 CARTRIDGE in 1 CARTON (0409-1176-30) / 1 mL in 1 CARTRIDGE (0409-1176-03) |
| DEMEROL | meperidine hydrochloride | INJECTABLE;INJECTION | 021171 | NDA | Hospira, Inc. | 0409-1178 | 0409-1178-30 | 10 CARTRIDGE in 1 CARTON (0409-1178-30) / 1 mL in 1 CARTRIDGE (0409-1178-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 25MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 75MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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