OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
3334217307
30 TABLET, FILM COATED in 1 BOTTLE (33342-173-07)
ndc11
3334217310
90 TABLET, FILM COATED in 1 BOTTLE (33342-173-10)
ndc11
3334217312
10 BLISTER PACK in 1 CARTON (33342-173-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
3334217344
1000 TABLET, FILM COATED in 1 BOTTLE (33342-173-44)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A204801

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": "33342-173_79da177b-5eeb-4d95-b949-251b7e8c948b",
  "productndc": "33342-173",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204801",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;20MG",
        "product_no": "001",
        "approval_date": "Jun 1, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG;40MG",
        "product_no": "002",
        "approval_date": "Jun 1, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;40MG",
        "product_no": "003",
        "approval_date": "Jun 1, 2023"
      }
    ],
    "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": "ANDA204801",
  "marketing_category": "ANDA",
  "nonproprietary_name": "OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE",
  "start_marketing_date": "20230602",
  "active_numerator_strength": "12.5; 20"
}

Related drugs

Other records sharing ATC code C03AA.

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