NDC 0093-0109

Carbamazepine

Carbamazepine

Carbamazepine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa,. The primary component is Carbamazepine.

Product ID0093-0109_0c7d3b04-e46e-443a-89c8-6092849e19b4
NDC0093-0109
Product TypeHuman Prescription Drug
Proprietary NameCarbamazepine
Generic NameCarbamazepine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1990-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA070541
Labeler NameTeva Pharmaceuticals USA,
Substance NameCARBAMAZEPINE
Active Ingredient Strength200 mg/1
Pharm ClassesDecreased Centr
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0093-0109-01

100 TABLET in 1 BOTTLE (0093-0109-01)
Marketing Start Date1990-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-0109-10 [00093010910]

Carbamazepine TABLET
Marketing CategoryANDA
Application NumberANDA070541
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1990-09-30

NDC 0093-0109-83 [00093010983]

Carbamazepine TABLET
Marketing CategoryANDA
Application NumberANDA070541
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-05
Marketing End Date2013-02-21

NDC 0093-0109-01 [00093010901]

Carbamazepine TABLET
Marketing CategoryANDA
Application NumberANDA070541
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1990-09-30

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE200 mg/1

OpenFDA Data

SPL SET ID:bfd63965-56e6-4af7-b7ef-45a5105d4d35
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308973
  • 308979
  • UPC Code
  • 0300930109010
  • 0300930778018
  • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Mood Stabilizer [EPC]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 1A2 Inducers [MoA]
    • Cytochrome P450 2B6 Inducers [MoA]
    • Cytochrome P450 2C9 Inducers [MoA]
    • Cytochrome P450 2C19 Inducers [MoA]

    NDC Crossover Matching brand name "Carbamazepine" or generic name "Carbamazepine"

    NDCBrand NameGeneric Name
    0093-0109CarbamazepineCarbamazepine
    0093-0778CarbamazepineCarbamazepine
    68071-3282CarbamazepineCarbamazepine
    68071-4313CARBAMAZEPINECARBAMAZEPINE
    68084-444CarbamazepineCarbamazepine
    68094-007CarbamazepineCarbamazepine
    68094-008CarbamazepineCarbamazepine
    68382-555carbamazepinecarbamazepine
    68382-556carbamazepinecarbamazepine
    68382-557carbamazepinecarbamazepine
    68788-7210CARBAMAZEPINECARBAMAZEPINE
    68788-9492CARBAMAZEPINECARBAMAZEPINE
    68788-9812CarbamazepineCarbamazepine
    69189-0410CarbamazepineCarbamazepine
    70518-0181CarbamazepineCarbamazepine
    70518-0124CarbamazepineCarbamazepine
    70518-0902CARBAMAZEPINECARBAMAZEPINE
    70518-1769CarbamazepineCarbamazepine
    70518-1436CarbamazepineCarbamazepine
    70518-1545CarbamazepineCarbamazepine
    70518-1433CarbamazepineCarbamazepine
    70771-1470carbamazepinecarbamazepine
    70771-1469carbamazepinecarbamazepine
    70771-1468carbamazepinecarbamazepine
    71205-025CARBAMAZEPINECARBAMAZEPINE
    71335-0461CarbamazepineCarbamazepine
    71335-0462CARBAMAZEPINECARBAMAZEPINE
    0615-3505CarbamazepineCarbamazepine
    71335-0691CARBAMAZEPINECARBAMAZEPINE
    0615-4515CARBAMAZEPINECARBAMAZEPINE
    0904-3854CARBAMAZEPINECARBAMAZEPINE
    0904-6172CARBAMAZEPINECARBAMAZEPINE
    13668-271CARBAMAZEPINECARBAMAZEPINE
    13668-268CARBAMAZEPINECARBAMAZEPINE
    17856-4047CarbamazepineCarbamazepine
    21695-724CarbamazepineCarbamazepine
    29033-004CarbamazepineCarbamazepine
    33261-676CarbamazepineCarbamazepine
    43063-328CarbamazepineCarbamazepine
    43353-953CARBAMAZEPINECARBAMAZEPINE
    49999-616CARBAMAZEPINECARBAMAZEPINE
    50090-2161CARBAMAZEPINECARBAMAZEPINE
    51079-385CarbamazepineCarbamazepine
    51079-870CarbamazepineCarbamazepine
    51655-017CARBAMAZEPINECARBAMAZEPINE
    51672-4047CarbamazepineCarbamazepine
    51672-4151CarbamazepineCarbamazepine
    51672-4124CarbamazepineCarbamazepine
    51672-4125CarbamazepineCarbamazepine
    51672-4149CarbamazepineCarbamazepine

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.