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United States · US · US:43547-392_23c860d3-1b9a-4113-bab4-b803492bf7d7

OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerSolco Healthcare US, LLC
CountryUS (United States)
ATC codeC03AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4354739203
    30 TABLET in 1 BOTTLE (43547-392-03)
  • ndc11
    4354739209
    90 TABLET in 1 BOTTLE (43547-392-09)
  • ndc11
    4354739211
    1000 TABLET in 1 BOTTLE (43547-392-11)

Annotations

UNII (FDA Substance ID)
0J48LPH2TH
HYDROCHLOROTHIAZIDE
RxCUI 5487
Orange Book
A207804
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": "43547-392_23c860d3-1b9a-4113-bab4-b803492bf7d7",
  "productndc": "43547-392",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207804",
    "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": "ANDA207804",
  "marketing_category": "ANDA",
  "nonproprietary_name": "olmesartan medoxomil and hydrochlorothiazide",
  "start_marketing_date": "20170424",
  "active_numerator_strength": "12.5; 40"
}

Related drugs

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