NDC 61919-984

CARVEDILOL

Carvedilol

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

Product ID61919-984_494be2b0-1459-481f-e054-00144ff88e88
NDC61919-984
Product TypeHuman Prescription Drug
Proprietary NameCARVEDILOL
Generic NameCarvedilol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-02-24
Marketing CategoryANDA / ANDA
Application NumberANDA078332
Labeler NameDIRECT RX
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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61919-984-30

30 TABLET, FILM COATED in 1 BOTTLE (61919-984-30)
Marketing Start Date2017-02-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-984-90 [61919098490]

CARVEDILOL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078332
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-26

NDC 61919-984-30 [61919098430]

CARVEDILOL TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078332
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-02-24
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
CARVEDILOL6.25 mg/1

OpenFDA Data

SPL SET ID:494be2b0-1458-481f-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 200031
  • 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

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