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United States Β· US Β· US:65219-665_ccb1a15e-c943-4042-ae46-550bdabfc96b

Metoprolol

In shortageOrange BookUNIISPLATC C07AB02

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeC07AB02
Dispensingβ€”
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs Β· 1

  • ndc11
    6521966505
    10 VIAL in 1 TRAY (65219-665-05) / 5 mL in 1 VIAL (65219-665-01)

Annotations

UNII (FDA Substance ID)
W5S57Y3A5L
METOPROLOL TARTRATE
RxCUI 203191
Orange Book
A091045
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Metoprolol Tartrate Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "W5S57Y3A5L",
    "rxcui": "203191",
    "inchikey": "YGULWPYYGQCFMP-CEAXSRTFSA-N",
    "display_name": "METOPROLOL TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "65219-665_ccb1a15e-c943-4042-ae46-550bdabfc96b",
  "productndc": "65219-665",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "091045",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "001",
        "approval_date": "Oct 25, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METOPROLOL TARTRATE",
  "shortage_reason": "Metoprolol Tartrate Tablet",
  "shortage_status": "current",
  "proprietary_name": "Metoprolol",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA091045",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METOPROLOL TARTRATE",
  "start_marketing_date": "20241213",
  "active_numerator_strength": "5"
}

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