NDC 0781-5987

Carbamazepine ER

Carbamazepine

Carbamazepine ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Carbamazepine.

Product ID0781-5987_546468c0-441c-4689-889c-c0c01e9c279f
NDC0781-5987
Product TypeHuman Prescription Drug
Proprietary NameCarbamazepine ER
Generic NameCarbamazepine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date1996-03-25
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020234
Labeler NameSandoz 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 0781-5987-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-5987-01)
Marketing Start Date1996-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-5987-01 [00781598701]

Carbamazepine ER TABLET, EXTENDED RELEASE
Marketing CategoryNDA authorized generic
Application NumberNDA020234
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-03-25

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE200 mg/1

OpenFDA Data

SPL SET ID:3a3344dc-9cc8-41da-859e-295d053597c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199378
  • 402505
  • 402506
  • 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 "Carbamazepine ER" or generic name "Carbamazepine"

    NDCBrand NameGeneric Name
    68084-562Carbamazepine ERCarbamazepine ER
    68084-561Carbamazepine ERCarbamazepine ER
    0781-5988Carbamazepine ERCarbamazepine ER
    0781-5987Carbamazepine ERCarbamazepine ER
    0781-8016Carbamazepine ERCarbamazepine ER
    70518-2653Carbamazepine ERCarbamazepine ER
    0093-0109CarbamazepineCarbamazepine
    0093-0778CarbamazepineCarbamazepine
    0093-0090EpitolCarbamazepine
    0078-0508Tegretolcarbamazepine
    0078-0509Tegretolcarbamazepine
    0078-0510Tegretolcarbamazepine
    0078-0511Tegretolcarbamazepine
    0078-0512Tegretolcarbamazepine

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