NDC 68094-007

Carbamazepine

Carbamazepine

Carbamazepine is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Precision Dose, Inc.. The primary component is Carbamazepine.

Product ID68094-007_279d3e28-03c4-451d-895b-5ebb4fb4b8d7
NDC68094-007
Product TypeHuman Prescription Drug
Proprietary NameCarbamazepine
Generic NameCarbamazepine
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2017-10-04
Marketing CategoryANDA / ANDA
Application NumberANDA075714
Labeler NamePrecision Dose, Inc.
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 Through2020-12-31

Packaging

NDC 68094-007-62

3 TRAY in 1 CASE (68094-007-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-007-59)
Marketing Start Date2017-10-04
Marketing End Date2023-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68094-007-62 [68094000762]

Carbamazepine SUSPENSION
Marketing CategoryANDA
Application NumberANDA075714
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-04

NDC 68094-007-59 [68094000759]

Carbamazepine SUSPENSION
Marketing CategoryANDA
Application NumberANDA075714
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-04

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE100 mg/5mL

OpenFDA Data

SPL SET ID:b0655a23-fea0-4a8c-aec2-e0e636528eb1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308976
  • 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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