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United States · US · US:62332-115_10e75c6b-f79e-4424-b4c1-0ea73a98c64d

Metoprolol Tartrate and Hydrochlorothiazide

In shortageOrange BookUNIISPLATC C03AA

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.
CountryUS (United States)
ATC codeC03AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6233211530
    30 TABLET in 1 BOTTLE (62332-115-30)
  • ndc11
    6233211531
    100 TABLET in 1 BOTTLE (62332-115-31)
  • ndc11
    6233211591
    1000 TABLET in 1 BOTTLE (62332-115-91)

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": "62332-115_10e75c6b-f79e-4424-b4c1-0ea73a98c64d",
  "productndc": "62332-115",
  "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": "20151015",
  "active_numerator_strength": "25; 50"
}

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