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.
pyrazinamide tablet
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-735
Application NumberANDA080157
Product Classification
M
Marketing Category
C73584
G
Generic Name
pyrazinamide tablet
Product Specifications
Route of AdministrationORAL
Effective DateDecember 4, 2023
FDA Product Classification
INGREDIENTS (4)
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