NDC 63187-409

Carvedilol

Carvedilol

Carvedilol is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Carvedilol.

Product ID63187-409_3ba72f70-229d-44ac-9cb1-dcc090332fb7
NDC63187-409
Product TypeHuman Prescription Drug
Proprietary NameCarvedilol
Generic NameCarvedilol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-09-05
Marketing CategoryANDA / ANDA
Application NumberANDA078332
Labeler NameProficient Rx LP
Substance NameCARVEDILOL
Active Ingredient Strength25 mg/1
Pharm ClassesAdrenergic alpha-Antagonists [MoA],Adrenergic beta1-Antagonists [MoA],Adrenergic beta2-Antagonists [MoA],alpha-Adrenergic Blocker [EPC],beta-Adrenergic Blocker [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63187-409-30

30 TABLET, FILM COATED in 1 BOTTLE (63187-409-30)
Marketing Start Date2018-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-409-90 [63187040990]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078332
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

NDC 63187-409-30 [63187040930]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078332
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-01

NDC 63187-409-60 [63187040960]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078332
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-12-01

Drug Details

Active Ingredients

IngredientStrength
CARVEDILOL25 mg/1

OpenFDA Data

SPL SET ID:cd7e7c34-6958-47be-a1c1-f1ed948e2687
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200033
  • 200032
  • Pharmacological Class

    • Adrenergic alpha-Antagonists [MoA]
    • Adrenergic beta1-Antagonists [MoA]
    • Adrenergic beta2-Antagonists [MoA]
    • alpha-Adrenergic Blocker [EPC]
    • beta-Adrenergic Blocker [EPC]

    NDC Crossover Matching brand name "Carvedilol" or generic name "Carvedilol"

    NDCBrand NameGeneric Name
    0093-0051CarvedilolCarvedilol
    0093-0135CarvedilolCarvedilol
    0093-7295CarvedilolCarvedilol
    0093-7296CarvedilolCarvedilol
    0378-3631Carvedilolcarvedilol
    0378-3632Carvedilolcarvedilol
    0378-3633Carvedilolcarvedilol
    0378-3634Carvedilolcarvedilol
    0615-6583CarvedilolCarvedilol
    0615-6584CarvedilolCarvedilol
    0615-6585CarvedilolCarvedilol
    0615-6586CarvedilolCarvedilol
    0615-7944CarvedilolCarvedilol
    68001-152CarvedilolCarvedilol
    68001-153CarvedilolCarvedilol
    68001-154CarvedilolCarvedilol
    68001-151CarvedilolCarvedilol
    68071-1962CarvedilolCarvedilol
    68071-1901CarvedilolCarvedilol
    68071-1954CarvedilolCarvedilol
    68071-3078CarvedilolCarvedilol
    68071-3026CarvedilolCarvedilol
    68071-3138CarvedilolCarvedilol
    68071-1935CarvedilolCarvedilol
    68071-3151CarvedilolCarvedilol
    68071-3269CarvedilolCarvedilol
    68071-4470CarvedilolCarvedilol
    68071-4495CarvedilolCarvedilol
    68071-4816CarvedilolCarvedilol
    68071-4600CarvedilolCarvedilol
    68084-843CarvedilolCarvedilol
    68084-854CarvedilolCarvedilol
    68084-876CarvedilolCarvedilol
    68084-865CarvedilolCarvedilol
    68382-094CarvedilolCarvedilol
    68382-095CarvedilolCarvedilol
    68382-092CarvedilolCarvedilol
    68382-093CarvedilolCarvedilol
    68462-162CarvedilolCarvedilol
    68462-164CarvedilolCarvedilol
    68462-165CarvedilolCarvedilol
    68462-163CarvedilolCarvedilol
    68645-350CarvedilolCarvedilol
    68645-496CarvedilolCarvedilol
    68645-351CarvedilolCarvedilol
    68788-0999CarvedilolCarvedilol
    68788-0254CarvedilolCarvedilol
    68788-6817CarvedilolCarvedilol
    68788-0253CarvedilolCarvedilol
    68788-6819CarvedilolCarvedilol

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.