Carbamazepine
CARBAMAZEPINE TABLETS USP, 200 mg/CARBAMAZEPINE CHEWABLE TABLETS USP, 100 mg01090778Rx only
Approved
Approval ID
8e06995c-26c9-4ef3-9421-16a2360db628
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2010
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
Products 1
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 Code67046-086
Application NumberANDA070541
Product Classification
M
Marketing Category
C73584
G
Generic Name
Carbamazepine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2006
FDA Product Classification
INGREDIENTS (7)
CARBAMAZEPINEActive
Quantity: 200 mg in 1 1
Code: 33CM23913M
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT