NDC 0378-3631

Carvedilol

Carvedilol

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

Product ID0378-3631_6ca13a77-e168-4456-a49c-50dad91eb7f2
NDC0378-3631
Product TypeHuman Prescription Drug
Proprietary NameCarvedilol
Generic NameCarvedilol
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-09-05
Marketing CategoryANDA / ANDA
Application NumberANDA077316
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCARVEDILOL
Active Ingredient Strength3 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 Through2022-12-31

Packaging

NDC 0378-3631-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3631-01)
Marketing Start Date2007-09-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-3631-02 [00378363102]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077316
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-15
Marketing End Date2015-02-04

NDC 0378-3631-28 [00378363128]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077316
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2007-09-05
Marketing End Date2015-03-03

NDC 0378-3631-91 [00378363191]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077316
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-05
Marketing End Date2015-03-03

NDC 0378-3631-05 [00378363105]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077316
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-09-05

NDC 0378-3631-07 [00378363107]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077316
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-08-15
Marketing End Date2015-02-04

NDC 0378-3631-01 [00378363101]

Carvedilol TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077316
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-09-05

Drug Details

Active Ingredients

IngredientStrength
CARVEDILOL3.125 mg/1

OpenFDA Data

SPL SET ID:e5026c19-733f-41a4-a0c9-e48a9a742460
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 686924
  • 200031
  • 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
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