Carbamazepine
CARBAMAZEPINE Extended-Release Capsules 100 mg, 200 mg and 300 mg
Approved
Approval ID
7a1e523a-b377-43dc-b231-7591c4c888ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2023
Manufacturers
FDA
Prasco Laboratories
DUNS: 065969375
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 Code66993-408
Application NumberNDA020712
Product Classification
M
Marketing Category
C73605
G
Generic Name
carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2023
FDA Product Classification
INGREDIENTS (18)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
CARBAMAZEPINEActive
Quantity: 200 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YY
Classification: IACT
carbamazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-409
Application NumberNDA020712
Product Classification
M
Marketing Category
C73605
G
Generic Name
carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2023
FDA Product Classification
INGREDIENTS (18)
CARBAMAZEPINEActive
Quantity: 300 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YY
Classification: IACT
carbamazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-407
Application NumberNDA020712
Product Classification
M
Marketing Category
C73605
G
Generic Name
carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2023
FDA Product Classification
INGREDIENTS (16)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CARBAMAZEPINEActive
Quantity: 100 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive
Code: NX76LV5T8J
Classification: IACT
AMMONIO METHACRYLATE COPOLYMER TYPE AInactive
Code: 8GQS4E66YY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT