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United States · US · US:71610-035_f94f454a-2f40-4d6b-8936-57fad107a20b

TOPROL

In shortageOrange BookUNIISPLATC C07AB02

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeC07AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7161003545
    45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-035-45)
  • ndc11
    7161003560
    90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-035-60)

Annotations

UNII (FDA Substance ID)
TH25PD4CCB
METOPROLOL SUCCINATE
RxCUI 221124
Orange Book
N019962
ABABABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Metoprolol Tartrate Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "TH25PD4CCB",
    "rxcui": "221124",
    "inchikey": "RGHAZVBIOOEVQX-UHFFFAOYSA-N",
    "display_name": "METOPROLOL SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "496ddfaa-7c9c-4888-b747-a210249b367a": {
      "match": "brand_token",
      "title": "TOPROL XL (METOPROLOL SUCCINATE) TABLET, EXTENDED RELEASE [MELINTA THERAPEUTICS, LLC]",
      "spl_version": "7",
      "published_date": "2026-03-06"
    }
  },
  "productid": "71610-035_f94f454a-2f40-4d6b-8936-57fad107a20b",
  "productndc": "71610-035",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "019962",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 50MG TARTRATE",
        "product_no": "001",
        "approval_date": "Jan 10, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 100MG TARTRATE",
        "product_no": "002",
        "approval_date": "Jan 10, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 200MG TARTRATE",
        "product_no": "003",
        "approval_date": "Jan 10, 1992"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 25MG TARTRATE",
        "product_no": "004",
        "approval_date": "Feb 5, 2001"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METOPROLOL SUCCINATE",
  "shortage_reason": "Metoprolol Tartrate Tablet",
  "shortage_status": "current",
  "proprietary_name": "TOPROL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019962",
  "marketing_category": "NDA",
  "nonproprietary_name": "Metoprolol succinate",
  "start_marketing_date": "20180101",
  "active_numerator_strength": "25"
}

Related drugs

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