NDC 0078-0512

Tegretol XR

Carbamazepine

Tegretol XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Carbamazepine.

Product ID0078-0512_222ae133-8914-48e4-8921-7bcf5906e118
NDC0078-0512
Product TypeHuman Prescription Drug
Proprietary NameTegretol XR
Generic NameCarbamazepine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date1996-03-25
Marketing CategoryNDA / NDA
Application NumberNDA020234
Labeler NameNovartis Pharmaceuticals Corporation
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 Through2021-12-31

Packaging

NDC 0078-0512-05

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0078-0512-05)
Marketing Start Date1996-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0512-05 [00078051205]

Tegretol XR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-03-25

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE400 mg/1

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 XR" or generic name "Carbamazepine"

    NDCBrand NameGeneric Name
    70518-0337Tegretol XRTegretol XR
    0093-0109CarbamazepineCarbamazepine
    0093-0778CarbamazepineCarbamazepine
    0093-0090EpitolCarbamazepine
    0078-0508Tegretolcarbamazepine
    0078-0509Tegretolcarbamazepine
    0078-0510Tegretolcarbamazepine
    0078-0511Tegretolcarbamazepine
    0078-0512Tegretolcarbamazepine

    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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