OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6787745330
30 TABLET, FILM COATED in 1 BOTTLE (67877-453-30)
ndc11
6787745390
90 TABLET, FILM COATED in 1 BOTTLE (67877-453-90)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A207037

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": "67877-453_ffb1336b-75c4-483d-85d9-17b78237e915",
  "productndc": "67877-453",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "207037",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "001",
        "approval_date": "Jul 11, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;40MG",
        "product_no": "002",
        "approval_date": "Jul 11, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;40MG",
        "product_no": "003",
        "approval_date": "Jul 11, 2024"
      }
    ],
    "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": "ANDA207037",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE",
  "start_marketing_date": "20250501",
  "active_numerator_strength": "12.5; 20"
}

Related drugs

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