NDC 60505-2807

Carbamazepine

Carbamazepine

Carbamazepine is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Apotex Corp.. The primary component is Carbamazepine.

Product ID60505-2807_18dffebb-680a-7c06-f539-400ae30e4acb
NDC60505-2807
Product TypeHuman Prescription Drug
Proprietary NameCarbamazepine
Generic NameCarbamazepine
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-03-23
Marketing End Date2023-03-31
Marketing CategoryANDA / ANDA
Application NumberANDA078986
Labeler NameApotex Corp.
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

Packaging

NDC 60505-2807-3

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2807-3)
Marketing Start Date2012-03-23
Marketing End Date2023-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60505-2807-3 [60505280703]

Carbamazepine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078986
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-23
Marketing End Date2023-03-31

NDC 60505-2807-5 [60505280705]

Carbamazepine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078986
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-23
Marketing End Date2023-03-31

NDC 60505-2807-7 [60505280707]

Carbamazepine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078986
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-03-23
Marketing End Date2023-03-31

NDC 60505-2807-0 [60505280700]

Carbamazepine CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078986
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-23
Marketing End Date2018-09-21

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE300 mg/1

OpenFDA Data

SPL SET ID:e91f9de3-3fdd-0a6b-71ce-53a2cc142816
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 388311
  • 200131
  • 200133
  • UPC Code
  • 0360505280773
  • 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]

    Medicade Reported Pricing

    60505280707 CARBAMAZEPINE ER 300 MG CAP

    Pricing Unit: EA | Drug Type:

    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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