NDC 70771-1470

carbamazepine

Carbamazepine

carbamazepine is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Cadila Healthcare Limited. The primary component is Carbamazepine.

Product ID70771-1470_1f999fa5-a296-4ae4-866e-6fe5a5586d61
NDC70771-1470
Product TypeHuman Prescription Drug
Proprietary Namecarbamazepine
Generic NameCarbamazepine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2019-03-12
Marketing CategoryANDA / ANDA
Application NumberANDA205571
Labeler NameCadila Healthcare Limited
Substance NameCARBAMAZEPINE
Active Ingredient Strength400 mg/1
Pharm ClassesDecreased 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 Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70771-1470-1

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1470-1)
Marketing Start Date2019-03-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1470-4 [70771147004]

carbamazepine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205571
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-12

NDC 70771-1470-9 [70771147009]

carbamazepine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205571
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-12

NDC 70771-1470-1 [70771147001]

carbamazepine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205571
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-12

NDC 70771-1470-3 [70771147003]

carbamazepine TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA205571
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-03-12

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE400 mg/1

OpenFDA Data

SPL SET ID:d10e5f83-56db-4bc9-8c51-150a2e3e20ea
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199378
  • 402505
  • 402506
    • UPC Code
  • 0370771147014

    • 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]
    • 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
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