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Pyrazinamide

PYRAZINAMIDE TABLETS USP, 500 mg

Approved
Approval ID

2b5aef5f-d966-55e0-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 9, 2016

Manufacturers
FDA

Department of State Health Services, Pharmacy Branch

DUNS: 781992540

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 Code55695-026
Application NumberANDA081319
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pyrazinamide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2016
FDA Product Classification

INGREDIENTS (6)

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

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Pyrazinamide - FDA Drug Approval Details