Olmesartan medoxomil

Orange BookUNIISPLATC C09CA08

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeC09CA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
3334218007
30 TABLET in 1 BOTTLE (33342-180-07)
ndc11
3334218010
90 TABLET in 1 BOTTLE (33342-180-10)
ndc11
3334218012
10 BLISTER PACK in 1 CARTON (33342-180-12) / 10 TABLET in 1 BLISTER PACK
ndc11
3334218044
1000 TABLET in 1 BOTTLE (33342-180-44)

Annotations

UNII (FDA Substance ID)

6M97XTV3HD

OLMESARTAN MEDOXOMIL

RxCUI 118463

Orange Book

A204814

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6M97XTV3HD",
    "rxcui": "118463",
    "inchikey": "UQGKUQLKSCSZGY-UHFFFAOYSA-N",
    "display_name": "OLMESARTAN MEDOXOMIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7f78d14a-acf2-4f82-9d20-dfcbd5e9ffb3": {
      "match": "brand_token",
      "title": "OLMESARTAN MEDOXOMIL TABLET [A-S MEDICATION SOLUTIONS]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "33342-180_0e3686f3-0150-49d0-b359-dcd05fa98fd7",
  "productndc": "33342-180",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204814",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Apr 24, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Apr 24, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "003",
        "approval_date": "Apr 24, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLMESARTAN MEDOXOMIL",
  "proprietary_name": "Olmesartan medoxomil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204814",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olmesartan medoxomil",
  "start_marketing_date": "20170425",
  "active_numerator_strength": "40"
}

Related drugs

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