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Papaverine Hydrochloride

PAPAVERINE HYDROCHLORIDE INJECTION, USP

Approved
Approval ID

9e5e2ce4-7a57-4c61-a826-64c8d11d038e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 17, 2023

Manufacturers
FDA

American Regent, Inc.

DUNS: 002033710

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Papaverine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0517-4002
Product Classification
G
Generic Name
Papaverine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 17, 2023
FDA Product Classification

INGREDIENTS (5)

PAPAVERINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 mL
Code: 23473EC6BQ
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Papaverine Hydrochloride - FDA Drug Approval Details