NDC 51079-385

Carbamazepine

Carbamazepine

Carbamazepine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Inc.. The primary component is Carbamazepine.

Product ID51079-385_7bc19232-48e3-1fa2-e053-2a91aa0a304b
NDC51079-385
Product TypeHuman Prescription Drug
Proprietary NameCarbamazepine
Generic NameCarbamazepine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1995-09-28
Marketing CategoryANDA / ANDA
Application NumberANDA070541
Labeler NameMylan Institutional Inc.
Substance NameCARBAMAZEPINE
Active Ingredient Strength200 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 Through2019-12-31

Packaging

NDC 51079-385-20

100 BLISTER PACK in 1 CARTON (51079-385-20) > 1 TABLET in 1 BLISTER PACK (51079-385-01)
Marketing Start Date1995-09-28
Marketing End Date2021-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51079-385-01 [51079038501]

Carbamazepine TABLET
Marketing CategoryANDA
Application NumberANDA070541
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-09-28

NDC 51079-385-19 [51079038519]

Carbamazepine TABLET
Marketing CategoryANDA
Application NumberANDA070541
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-02-01
Marketing End Date2018-12-17

NDC 51079-385-17 [51079038517]

Carbamazepine TABLET
Marketing CategoryANDA
Application NumberANDA070541
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-09-28
Marketing End Date2018-12-17

NDC 51079-385-20 [51079038520]

Carbamazepine TABLET
Marketing CategoryANDA
Application NumberANDA070541
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-09-28

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE200 mg/1

OpenFDA Data

SPL SET ID:ccb97a82-315f-4a23-b98f-37d3a63ac381
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308973
  • 308979

    • 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]

    Medicade Reported Pricing

    51079038520 CARBAMAZEPINE 200 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079038519 CARBAMAZEPINE 200 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079038517 CARBAMAZEPINE 200 MG TABLET

    Pricing Unit: EA | Drug Type:

    51079038501 CARBAMAZEPINE 200 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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