Carbamazepine
CARBAMAZEPINE TABLETS USP 200 mgRx only
Approved
Approval ID
25cca2b1-9020-4d8a-bc22-b8063e57f9e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-724
Application NumberANDA074649
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2010
FDA Product Classification
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBAMAZEPINEActive
Quantity: 200 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT