NDC 0093-0090

Epitol

Carbamazepine

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

Product ID0093-0090_2a6353f7-c318-4543-b64e-b2f58cb777dd
NDC0093-0090
Product TypeHuman Prescription Drug
Proprietary NameEpitol
Generic NameCarbamazepine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1990-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA070541
Labeler NameTeva Pharmaceuticals USA, 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 Through2021-12-31

Packaging

NDC 0093-0090-01

100 TABLET in 1 BOTTLE (0093-0090-01)
Marketing Start Date1990-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-0090-83 [00093009083]

Epitol TABLET
Marketing CategoryANDA
Application NumberANDA070541
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-06
Marketing End Date2013-02-19

NDC 0093-0090-01 [00093009001]

Epitol 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:32bbe864-7374-44da-8c6e-e733f0648243
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308979
  • 211817
  • UPC Code
  • 0300930090011
  • 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 "Epitol" or generic name "Carbamazepine"

    NDCBrand NameGeneric Name
    0093-0090EpitolCarbamazepine
    0093-0109CarbamazepineCarbamazepine
    0093-0778CarbamazepineCarbamazepine
    0078-0508Tegretolcarbamazepine
    0078-0509Tegretolcarbamazepine
    0078-0510Tegretolcarbamazepine
    0078-0511Tegretolcarbamazepine
    0078-0512Tegretolcarbamazepine

    Trademark Results [Epitol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EPITOL
    EPITOL
    76371783 2699909 Live/Registered
    TEVA PHARMACEUTICAL INDUSTRIES LTD.
    2002-02-15

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