NDC 54092-173

Carbatrol

Carbamazepine

Carbatrol is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Carbamazepine.

Product ID54092-173_14fbfd3d-8615-476d-976c-ca86dd5a9765
NDC54092-173
Product TypeHuman Prescription Drug
Proprietary NameCarbatrol
Generic NameCarbamazepine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date1997-09-30
Marketing CategoryNDA / NDA
Application NumberNDA020712
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameCARBAMAZEPINE
Active Ingredient Strength300 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 54092-173-12

120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-173-12)
Marketing Start Date1997-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54092-173-12 [54092017312]

Carbatrol CAPSULE, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-09-30

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE300 mg/1

OpenFDA Data

SPL SET ID:bc03e499-5bac-4293-bff4-6864153a624d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308977
  • 313931
  • 200133
  • 388311
  • 200131
  • 404742
  • UPC Code
  • 0354092171125
  • 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]

    Medicade Reported Pricing

    54092017312 CARBATROL ER 300 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Carbatrol" or generic name "Carbamazepine"

    NDCBrand NameGeneric Name
    54092-173CarbatrolCarbatrol
    54092-171CarbatrolCarbatrol
    54092-172CarbatrolCarbatrol
    0093-0109CarbamazepineCarbamazepine
    0093-0778CarbamazepineCarbamazepine
    0093-0090EpitolCarbamazepine
    0078-0508Tegretolcarbamazepine
    0078-0509Tegretolcarbamazepine
    0078-0510Tegretolcarbamazepine
    0078-0511Tegretolcarbamazepine
    0078-0512Tegretolcarbamazepine

    Trademark Results [Carbatrol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CARBATROL
    CARBATROL
    74487208 1975246 Live/Registered
    SHIRE LLC
    1994-02-07

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