NDC 0078-0508

Tegretol

Carbamazepine

Tegretol is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Carbamazepine.

Product ID0078-0508_222ae133-8914-48e4-8921-7bcf5906e118
NDC0078-0508
Product TypeHuman Prescription Drug
Proprietary NameTegretol
Generic NameCarbamazepine
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date1987-12-18
Marketing CategoryNDA / NDA
Application NumberNDA018927
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameCARBAMAZEPINE
Active Ingredient Strength100 mg/5mL
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 0078-0508-83

450 mL in 1 BOTTLE (0078-0508-83)
Marketing Start Date1987-12-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0508-83 [00078050883]

Tegretol SUSPENSION
Marketing CategoryNDA
Application NumberNDA018927
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1987-12-18

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE100 mg/5mL

OpenFDA Data

SPL SET ID:8d409411-aa9f-4f3a-a52c-fbcb0c3ec053
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308972
  • 308971
  • 308976
  • 866305
  • 308979
  • 402505
  • 866307
  • 402506
  • 199378
  • 866303
  • 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 "Tegretol" or generic name "Carbamazepine"

    NDCBrand NameGeneric Name
    0078-0508Tegretolcarbamazepine
    0078-0509Tegretolcarbamazepine
    0078-0510Tegretolcarbamazepine
    0078-0511Tegretolcarbamazepine
    0078-0512Tegretolcarbamazepine
    70518-1452TegretolTegretol
    0093-0109CarbamazepineCarbamazepine
    0093-0778CarbamazepineCarbamazepine
    0093-0090EpitolCarbamazepine

    Trademark Results [Tegretol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TEGRETOL
    TEGRETOL
    72201286 0788091 Live/Registered
    GEIGY CHEMICAL CORPORTION
    1964-09-04

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