Carbamazepine
Carbamazepine Extended-Release Capsules 100 mg, 200 mg and 300 mg Rx only
Approved
Approval ID
33edb22f-f357-ec0f-e063-6394a90a7bc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 29, 2025
Manufacturers
FDA
Coupler LLC
DUNS: 119003108
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 Code67046-1559
Application NumberANDA076697
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateApril 29, 2025
FDA Product Classification
INGREDIENTS (17)
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
CARBAMAZEPINEActive
Quantity: 200 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
ETHYLCELLULOSE (20 MPA.S)Inactive
Code: BJG0S321QY
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT