Metoprolol Tartrate and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0378044501
100 TABLET in 1 BOTTLE, PLASTIC (0378-0445-01)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A076792

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": {
    "76c69d7c-e90c-4f96-a45b-e9dad9444263": {
      "match": "brand_token",
      "title": "METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]",
      "spl_version": "5",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0378-0445_771d61ce-0810-4998-b77b-9d3fe58056d9",
  "productndc": "0378-0445",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076792",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;50MG",
        "product_no": "001",
        "approval_date": "Aug 20, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "002",
        "approval_date": "Aug 20, 2004"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;100MG",
        "product_no": "003",
        "approval_date": "Aug 20, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE",
  "shortage_reason": "Hydrochlorothiazide; Quinapril Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Metoprolol Tartrate and Hydrochlorothiazide",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076792",
  "marketing_category": "ANDA",
  "nonproprietary_name": "metoprolol tartrate and hydrochlorothiazide",
  "start_marketing_date": "20040820",
  "active_numerator_strength": "50; 100"
}

Related drugs

Other records sharing ATC code C03AA.

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