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
NDC Product Code71335-1730
Application NumberANDA207798
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 21, 2021
Generic NameCarbamazepine
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