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Generated: November 12, 2018

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Details for New Drug Application (NDA): 021171

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NDA 021171 describes DEMEROL, which is a drug marketed by Hospira and Us Pharm Holdings 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. Nine 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021171
Mechanism of ActionFull 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 BOX (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 BOX (0409-1178-30) > 1 mL in 1 CARTRIDGE (0409-1178-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength75MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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