NDC 76385-111

Carvedilol

Carvedilol

Carvedilol is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bayshore Pharmaceuticals Llc. The primary component is Carvedilol.

Product ID76385-111_140d8e14-2e58-40fa-88a4-76f23e92a0f3
NDC76385-111
Product TypeHuman Prescription Drug
Proprietary NameCarvedilol
Generic NameCarvedilol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA078384
Labeler NameBayshore Pharmaceuticals LLC
Substance NameCARVEDILOL
Active Ingredient Strength6 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 Through2023-12-31

Packaging

NDC 76385-111-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-111-01)
Marketing Start Date2016-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76385-111-01 [76385011101]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078384
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-01

NDC 76385-111-50 [76385011150]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078384
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-01

Drug Details

Active Ingredients

IngredientStrength
CARVEDILOL6.25 mg/1

OpenFDA Data

SPL SET ID:33dfcf29-19d6-46ba-b8ed-d59d2226ad07
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 686924
  • 200031
  • 200033
  • 200032
    • UPC Code
  • 0376385110017
  • 0376385367688

    • Pharmacological Class

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

    Medicade Reported Pricing

    76385011150 CARVEDILOL 6.25 MG TABLET

    Pricing Unit: EA | Drug Type:

    76385011101 CARVEDILOL 6.25 MG TABLET

    Pricing Unit: EA | Drug Type:

    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.