Carbamazepine
Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg and 400 mg
Approved
Approval ID
48080efd-1781-4585-83f8-c43957ac63b3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2024
Manufacturers
FDA
UMEDICA LABORATORIES PRIVATE LIMITED
DUNS: 920635096
Products 3
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 Code60290-058
Application NumberANDA216594
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (15)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
ETHYLCELLULOSE AQUEOUS DISPERSION TYPE AInactive
Code: MX37N1DUF3
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CARBAMAZEPINEActive
Quantity: 100 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
Carbamazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60290-060
Application NumberANDA216594
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (15)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
ETHYLCELLULOSE AQUEOUS DISPERSION TYPE AInactive
Code: MX37N1DUF3
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CARBAMAZEPINEActive
Quantity: 400 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Carbamazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60290-059
Application NumberANDA216594
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2024
FDA Product Classification
INGREDIENTS (15)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)Inactive
Code: P2OM2Q86BI
Classification: IACT
ETHYLCELLULOSE AQUEOUS DISPERSION TYPE AInactive
Code: MX37N1DUF3
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2208 (3 MPA.S)Inactive
Code: 9H4L916OBU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CARBAMAZEPINEActive
Quantity: 200 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT