PYRAZINAMIDE

PYRAZINAMIDE - pyrazinamide tablet Marlex Pharmaceuticals, Inc.

Approved

Approval ID

db250a85-2e20-87e9-e053-2a95a90a72b6

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 4, 2023

Manufacturers

FDA

MARLEX PHARMACEUTICALS, INC

DUNS: 782540215

Products 1

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

NDC Product Code10135-735

Application NumberANDA080157

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateDecember 4, 2023

Generic Namepyrazinamide tablet

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

PYRAZINAMIDEActive

Quantity: 500 mg in 1 1

Code: 2KNI5N06TI

Classification: ACTIB