NDC 0378-0081

Captopril and Hydrochlorothiazide

Captopril And Hydrochlorothiazide

Captopril and Hydrochlorothiazide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Captopril; Hydrochlorothiazide.

Product ID0378-0081_2a59df64-9cc5-4f53-bb80-4d09ca5416c3
NDC0378-0081
Product TypeHuman Prescription Drug
Proprietary NameCaptopril and Hydrochlorothiazide
Generic NameCaptopril And Hydrochlorothiazide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1997-12-29
Marketing CategoryANDA / ANDA
Application NumberANDA074896
Labeler NameMylan Pharmaceuticals Inc.
Substance NameCAPTOPRIL; HYDROCHLOROTHIAZIDE
Active Ingredient Strength25 mg/1; mg/1
Pharm ClassesAngiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0378-0081-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0081-01)
Marketing Start Date1997-12-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0081-01 [00378008101]

Captopril and Hydrochlorothiazide TABLET
Marketing CategoryANDA
Application NumberANDA074896
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-12-29

Drug Details

Active Ingredients

IngredientStrength
CAPTOPRIL25 mg/1

OpenFDA Data

SPL SET ID:d826812e-ede7-49e7-8384-29ec5b142ef3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197436
  • 197437
  • 197438
  • 197439
  • Pharmacological Class

    • Angiotensin Converting Enzyme Inhibitor [EPC]
    • Angiotensin-converting Enzyme Inhibitors [MoA]
    • Increased Diuresis [PE]
    • Thiazide Diuretic [EPC]
    • Thiazides [CS]

    NDC Crossover Matching brand name "Captopril and Hydrochlorothiazide" or generic name "Captopril And Hydrochlorothiazide"

    NDCBrand NameGeneric Name
    0378-0081Captopril and Hydrochlorothiazidecaptopril and hydrochlorothiazide
    0378-0083Captopril and Hydrochlorothiazidecaptopril and hydrochlorothiazide
    0378-0084Captopril and Hydrochlorothiazidecaptopril and hydrochlorothiazide
    0378-0086Captopril and Hydrochlorothiazidecaptopril and hydrochlorothiazide

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