CARBAMAZEPINE
Carbamazepine Tablets, USP 200 mg – pink Rx only Prescribing Information
Approved
Approval ID
87d343a8-84d5-4cdd-b0a0-629311b51f11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CARBAMAZEPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-731
Application NumberANDA216623
Product Classification
M
Marketing Category
C73584
G
Generic Name
CARBAMAZEPINE
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (7)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBAMAZEPINEActive
Quantity: 200 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT