Carbamazepine
Carbamazepine Tablets USP, 100 mg and 200 mg Rx only Prescribing Information
Approved
Approval ID
62d38b93-7dd0-48e7-bd59-a434d52520f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 3, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code71335-1730
Application NumberANDA207798
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2021
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBAMAZEPINEActive
Quantity: 200 mg in 1 1
Code: 33CM23913M
Classification: ACTIB