Indapamide

Orange BookUNIISPLATC C03BA11

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerRising Pharma Holdings, Inc.

CountryUS (United States)

ATC codeC03BA11

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1657187501
100 TABLET in 1 BOTTLE (16571-875-01)

Annotations

UNII (FDA Substance ID)

F089I0511L

INDAPAMIDE

RxCUI 5764

Orange Book

A074461

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "F089I0511L",
    "rxcui": "5764",
    "inchikey": "NDDAHWYSQHTHNT-UHFFFAOYSA-N",
    "display_name": "INDAPAMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "59cd3331-7afe-432a-8b50-39533fd5f392": {
      "match": "brand_token",
      "title": "INDAPAMIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]",
      "spl_version": "9",
      "published_date": "2026-05-15"
    }
  },
  "productid": "16571-875_7c1bd14b-7f8f-4ad6-9c3c-e6a0d9aad1cf",
  "productndc": "16571-875",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074461",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Mar 27, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1.25MG",
        "product_no": "002",
        "approval_date": "Mar 26, 1997"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "INDAPAMIDE",
  "proprietary_name": "Indapamide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074461",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Indapamide",
  "start_marketing_date": "20230622",
  "active_numerator_strength": "1.25"
}

Related drugs

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