LOSARTAN POTASSIUM

Orange BookUNIISPLATC C09CA01

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC

CountryUS (United States)

ATC codeC09CA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7161046530
30 TABLET, FILM COATED in 1 BOTTLE (71610-465-30)
ndc11
7161046560
90 TABLET, FILM COATED in 1 BOTTLE (71610-465-60)

Annotations

UNII (FDA Substance ID)

3ST302B24A

LOSARTAN POTASSIUM

RxCUI 203160

Orange Book

A203835

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "3ST302B24A",
    "rxcui": "203160",
    "inchikey": "OXCMYAYHXIHQOA-UHFFFAOYSA-N",
    "display_name": "LOSARTAN POTASSIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5f7612dc-dccf-49e2-b541-3dab9dc1f97a": {
      "match": "brand_token",
      "title": "LOSARTAN POTASSIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "30",
      "published_date": "2026-06-01"
    }
  },
  "productid": "71610-465_03a7d931-b0de-41e6-99e0-0d4ff6cb78b8",
  "productndc": "71610-465",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203835",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "Aug 12, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "Aug 12, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Aug 12, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOSARTAN POTASSIUM",
  "proprietary_name": "LOSARTAN POTASSIUM",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203835",
  "marketing_category": "ANDA",
  "nonproprietary_name": "LOSARTAN POTASSIUM",
  "start_marketing_date": "20200313",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code C09CA01.

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