CARBAMAZEPINE ER
Carbamazepine Extended-Release Tablets, USP 100 mg, 200 mg, 400 mg Rx only Prescribing Information
Approved
Approval ID
b48741b3-0889-47b8-a26e-b12614f6e7fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
AustarPharma LLC
DUNS: 362785011
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 Code35561-355
Application NumberANDA215591
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (10)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM LAURETH SULFATEInactive
Code: BPV390UAP0
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
CARBAMAZEPINEActive
Quantity: 100 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
carbamazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35561-357
Application NumberANDA215591
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (10)
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
CARBAMAZEPINEActive
Quantity: 400 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
carbamazepine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code35561-356
Application NumberANDA215591
Product Classification
M
Marketing Category
C73584
G
Generic Name
carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2024
FDA Product Classification
INGREDIENTS (10)
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
BROWN IRON OXIDEInactive
Code: 1N032N7MFO
Classification: IACT
CARBAMAZEPINEActive
Quantity: 200 mg in 1 1
Code: 33CM23913M
Classification: ACTIB