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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 005010


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NDA 005010 describes DEMEROL, which is a drug marketed by Hospira and Validus Pharms 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.
Summary for 005010
Tradename:DEMEROL
Applicant:Validus Pharms
Ingredient:meperidine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 005010
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 005010
Suppliers and Packaging for NDA: 005010
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEMEROL meperidine hydrochloride INJECTABLE;INJECTION 005010 NDA Validus Pharmaceuticals LLC 30698-335 30698-335-01 100 TABLET in 1 BOTTLE, PLASTIC (30698-335-01)
DEMEROL meperidine hydrochloride SYRUP;ORAL 005010 NDA Validus Pharmaceuticals LLC 30698-335 30698-335-01 100 TABLET in 1 BOTTLE, PLASTIC (30698-335-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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