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Pyrazinamide

PYRAZINAMIDE TABLETS USP, 500 mg

Approved
Approval ID

fb6cc470-ba54-47df-aa90-13c545ed5016

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 4, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

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

Pyrazinamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-0520
Application NumberANDA081319
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pyrazinamide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2022
FDA Product Classification

INGREDIENTS (6)

PYRAZINAMIDEActive
Quantity: 500 mg in 1 1
Code: 2KNI5N06TI
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

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Pyrazinamide - FDA Drug Approval Details