Carbamazepine
CARBAMAZEPINE TABLETS, USP
Approved
Approval ID
6903e7ef-8b5c-4b64-a87d-62f1f102bc75
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 20, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CARBAMAZEPINE
PRODUCT DETAILS
NDC Product Code53808-0915
Application NumberANDA075948
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 20, 2010
Generic NameCARBAMAZEPINE
INGREDIENTS (7)
CARBAMAZEPINEActive
Quantity: 200 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARBAMAZEPINE
PRODUCT DETAILS
NDC Product Code53808-0916
Application NumberANDA074649
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 20, 2010
Generic NameCARBAMAZEPINE
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBAMAZEPINEActive
Quantity: 200 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
CARBAMAZEPINE
PRODUCT DETAILS
NDC Product Code53808-0913
Application NumberANDA074649
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 20, 2010
Generic NameCARBAMAZEPINE
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
CARBAMAZEPINEActive
Quantity: 100 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT