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United States · US · US:30698-460_494efa43-aa90-d6f4-e063-6294a90a11ac

LOPRESSOR

In shortageOrange BookUNIISPLATC C07AB02

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

Identification

ManufacturerVALIDUS PHARMACEUTICALS LLC
CountryUS (United States)
ATC codeC07AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    3069846001
    60 TABLET in 1 BOTTLE (30698-460-01)
  • ndc11
    3069846003
    30 TABLET in 1 BOTTLE (30698-460-03)
  • ndc11
    3069846010
    1000 TABLET in 1 BOTTLE (30698-460-10)

Annotations

UNII (FDA Substance ID)
W5S57Y3A5L
METOPROLOL TARTRATE
RxCUI 203191
Orange Book
N218698
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": "ORAL",
  "spl_meta": {
    "b5f4fed2-369c-4808-a682-8a5b8cfdbb4f": {
      "match": "brand_token",
      "title": "LOPRESSOR (METOPROLOL TARTRATE) TABLET [VALIDUS PHARMACEUTICALS LLC]",
      "spl_version": "3",
      "published_date": "2026-01-28"
    }
  },
  "productid": "30698-460_494efa43-aa90-d6f4-e063-6294a90a11ac",
  "productndc": "30698-460",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218698",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Aug 28, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METOPROLOL TARTRATE",
  "shortage_reason": "Metoprolol Tartrate Tablet",
  "shortage_status": "current",
  "proprietary_name": "LOPRESSOR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA218698",
  "marketing_category": "NDA",
  "nonproprietary_name": "METOPROLOL TARTRATE",
  "start_marketing_date": "20250811",
  "active_numerator_strength": "12.5"
}

Related drugs

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