NDC 68071-4313

CARBAMAZEPINE

Carbamazepine

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

Product ID68071-4313_66d627ff-5f1e-0a25-e053-2a91aa0afe24
NDC68071-4313
Product TypeHuman Prescription Drug
Proprietary NameCARBAMAZEPINE
Generic NameCarbamazepine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2002-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA075948
Labeler NameNuCare Pharmaceuticals,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 Through2020-12-31

Packaging

NDC 68071-4313-1

120 TABLET in 1 BOTTLE (68071-4313-1)
Marketing Start Date2018-03-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4313-9 [68071431309]

CARBAMAZEPINE TABLET
Marketing CategoryANDA
Application NumberANDA075948
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68071-4313-1 [68071431301]

CARBAMAZEPINE TABLET
Marketing CategoryANDA
Application NumberANDA075948
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68071-4313-6 [68071431306]

CARBAMAZEPINE TABLET
Marketing CategoryANDA
Application NumberANDA075948
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

NDC 68071-4313-3 [68071431303]

CARBAMAZEPINE TABLET
Marketing CategoryANDA
Application NumberANDA075948
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-07

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE200 mg/1

OpenFDA Data

SPL SET ID:66d627ff-5f1d-0a25-e053-2a91aa0afe24
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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]
    • 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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