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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0915
Application NumberANDA075948
Product Classification
M
Marketing Category
C73584
G
Generic Name
CARBAMAZEPINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2010
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0916
Application NumberANDA074649
Product Classification
M
Marketing Category
C73584
G
Generic Name
CARBAMAZEPINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2010
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0913
Application NumberANDA074649
Product Classification
M
Marketing Category
C73584
G
Generic Name
CARBAMAZEPINE
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2010
FDA Product Classification
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