Metoprolol Tartrate and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerAlembic Pharmaceuticals Limited

CountryUS (United States)

ATC codeC03AA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4670811610
100 TABLET in 1 BOTTLE (46708-116-10)
ndc11
4670811630
30 TABLET in 1 BOTTLE (46708-116-30)
ndc11
4670811650
500 TABLET in 1 BOTTLE (46708-116-50)

Annotations

UNII (FDA Substance ID)

0J48LPH2TH

HYDROCHLOROTHIAZIDE

RxCUI 5487

Orange Book

A202870

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": "46708-116_5afb35ed-f222-47c7-ac02-3b1d062b09d2",
  "productndc": "46708-116",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "202870",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;50MG",
        "product_no": "001",
        "approval_date": "Nov 6, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG;100MG",
        "product_no": "002",
        "approval_date": "Nov 6, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG;100MG",
        "product_no": "003",
        "approval_date": "Nov 6, 2013"
      }
    ],
    "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": "ANDA202870",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metoprolol Tartrate and Hydrochlorothiazide",
  "start_marketing_date": "20130917",
  "active_numerator_strength": "25; 100"
}

Related drugs

Other records sharing ATC code C03AA.

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