Pyrazinamide
PYRAZINAMIDE Tablets, USP 500 mg
Approved
Approval ID
a8b7ba02-8509-475b-8a3b-39d205af3f1e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2022
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
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 Code33342-447
Application NumberANDA212541
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pyrazinamide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2022
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PYRAZINAMIDEActive
Quantity: 500 mg in 1 1
Code: 2KNI5N06TI
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT