NDC 53808-0915

Carbamazepine

Carbamazepine

Carbamazepine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Carbamazepine.

Product ID53808-0915_18def499-cbff-49a0-bdf7-dd5d38fc6f01
NDC53808-0915
Product TypeHuman Prescription Drug
Proprietary NameCarbamazepine
Generic NameCarbamazepine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA075948
Labeler NameState of Florida DOH Central Pharmacy
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 53808-0915-1

30 TABLET in 1 BLISTER PACK (53808-0915-1)
Marketing Start Date2009-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53808-0915-1 [53808091501]

Carbamazepine TABLET
Marketing CategoryANDA
Application NumberANDA075948
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-07-01
Inactivation Date2019-10-21

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE200 mg/1

OpenFDA Data

SPL SET ID:6903e7ef-8b5c-4b64-a87d-62f1f102bc75
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308979
  • 197441
  • UPC Code
  • 0360505018314
  • 0351672400521
  • 0351672404123
  • 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" or generic name "Carbamazepine"

    NDCBrand NameGeneric Name
    0093-0109CarbamazepineCarbamazepine
    0093-0778CarbamazepineCarbamazepine
    68071-3282CarbamazepineCarbamazepine
    68071-4313CARBAMAZEPINECARBAMAZEPINE
    68084-444CarbamazepineCarbamazepine
    68094-007CarbamazepineCarbamazepine
    68094-008CarbamazepineCarbamazepine
    68382-555carbamazepinecarbamazepine
    68382-556carbamazepinecarbamazepine
    68382-557carbamazepinecarbamazepine
    68788-7210CARBAMAZEPINECARBAMAZEPINE
    68788-9492CARBAMAZEPINECARBAMAZEPINE
    68788-9812CarbamazepineCarbamazepine
    69189-0410CarbamazepineCarbamazepine
    70518-0181CarbamazepineCarbamazepine
    70518-0124CarbamazepineCarbamazepine
    70518-0902CARBAMAZEPINECARBAMAZEPINE
    70518-1769CarbamazepineCarbamazepine
    70518-1436CarbamazepineCarbamazepine
    70518-1545CarbamazepineCarbamazepine
    70518-1433CarbamazepineCarbamazepine
    70771-1470carbamazepinecarbamazepine
    70771-1469carbamazepinecarbamazepine
    70771-1468carbamazepinecarbamazepine
    71205-025CARBAMAZEPINECARBAMAZEPINE
    71335-0461CarbamazepineCarbamazepine
    71335-0462CARBAMAZEPINECARBAMAZEPINE
    0615-3505CarbamazepineCarbamazepine
    71335-0691CARBAMAZEPINECARBAMAZEPINE
    0615-4515CARBAMAZEPINECARBAMAZEPINE
    0904-3854CARBAMAZEPINECARBAMAZEPINE
    0904-6172CARBAMAZEPINECARBAMAZEPINE
    13668-271CARBAMAZEPINECARBAMAZEPINE
    13668-268CARBAMAZEPINECARBAMAZEPINE
    17856-4047CarbamazepineCarbamazepine
    21695-724CarbamazepineCarbamazepine
    29033-004CarbamazepineCarbamazepine
    33261-676CarbamazepineCarbamazepine
    43063-328CarbamazepineCarbamazepine
    43353-953CARBAMAZEPINECARBAMAZEPINE
    49999-616CARBAMAZEPINECARBAMAZEPINE
    50090-2161CARBAMAZEPINECARBAMAZEPINE
    51079-385CarbamazepineCarbamazepine
    51079-870CarbamazepineCarbamazepine
    51655-017CARBAMAZEPINECARBAMAZEPINE
    51672-4047CarbamazepineCarbamazepine
    51672-4151CarbamazepineCarbamazepine
    51672-4124CarbamazepineCarbamazepine
    51672-4125CarbamazepineCarbamazepine
    51672-4149CarbamazepineCarbamazepine

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