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United States · US · US:50090-3701_0a66c75f-394d-4ce8-9eb7-79cbbb12a584

Olmesartan Medoxomil and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeC03AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009037010
    30 TABLET, FILM COATED in 1 BOTTLE (50090-3701-0)
  • ndc11
    5009037011
    90 TABLET, FILM COATED in 1 BOTTLE (50090-3701-1)

Annotations

UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A205391
ABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Hydrochlorothiazide; Quinapril Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "0J48LPH2TH",
    "rxcui": "5487",
    "inchikey": "JZUFKLXOESDKRF-UHFFFAOYSA-N",
    "display_name": "HYDROCHLOROTHIAZIDE",
    "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": "50090-3701_0a66c75f-394d-4ce8-9eb7-79cbbb12a584",
  "productndc": "50090-3701",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205391",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "001",
        "approval_date": "Apr 24, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;40MG",
        "product_no": "002",
        "approval_date": "Apr 24, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;40MG",
        "product_no": "003",
        "approval_date": "Apr 24, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Olmesartan Medoxomil and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA205391",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Olmesartan Medoxomil and Hydrochlorothiazide",
  "start_marketing_date": "20170424",
  "active_numerator_strength": "12.5; 20"
}

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