NDC 0378-0080

Indapamide

Indapamide

Indapamide 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 Indapamide.

Product ID0378-0080_a92c5cdc-8cb6-44ad-ae7d-d6f415f1e8c6
NDC0378-0080
Product TypeHuman Prescription Drug
Proprietary NameIndapamide
Generic NameIndapamide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1996-03-28
Marketing CategoryANDA / ANDA
Application NumberANDA074461
Labeler NameMylan Pharmaceuticals Inc.
Substance NameINDAPAMIDE
Active Ingredient Strength3 mg/1
Pharm ClassesIncreased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0378-0080-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0080-01)
Marketing Start Date1996-03-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0080-77 [00378008077]

Indapamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074461
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-16

NDC 0378-0080-01 [00378008001]

Indapamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074461
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-03-28

NDC 0378-0080-10 [00378008010]

Indapamide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA074461
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-03-28

Drug Details

Active Ingredients

IngredientStrength
INDAPAMIDE2.5 mg/1

OpenFDA Data

SPL SET ID:5c098a1b-cca0-4c27-8e0e-3a27cb2fc003
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197816
  • 197815
  • Pharmacological Class

    • Increased Diuresis [PE]
    • Thiazide-like Diuretic [EPC]
    • Increased Diuresis [PE]
    • Thiazide-like Diuretic [EPC]

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

    NDCBrand NameGeneric Name
    0228-2571IndapamideIndapamide
    0228-2597IndapamideIndapamide
    0378-0069IndapamideIndapamide
    0378-0080IndapamideIndapamide
    21695-576IndapamideIndapamide
    42291-348IndapamideIndapamide
    42291-349IndapamideIndapamide
    43975-217INDAPAMIDEINDAPAMIDE
    43975-304INDAPAMIDEINDAPAMIDE
    50090-0510IndapamideIndapamide
    51079-868IndapamideIndapamide
    51407-024IndapamideIndapamide
    51407-025IndapamideIndapamide
    55700-281IndapamideIndapamide
    55700-641IndapamideIndapamide
    62559-510IndapamideIndapamide
    62559-511IndapamideIndapamide
    63629-1953IndapamideIndapamide
    63629-1954IndapamideIndapamide
    68151-1294IndapamideIndapamide
    68788-7247IndapamideIndapamide
    70518-1324IndapamideIndapamide
    63629-7892IndapamideIndapamide
    71335-1541IndapamideIndapamide

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