TOPROL XL

In shortageOrange BookUNIISPLATC C07AB02

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

Identification

ManufacturerMelinta Therapeutics, LLC

CountryUS (United States)

ATC codeC07AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7084211202
100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70842-112-02)

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": "70842-112_a9037cc4-2d8d-45d5-9b89-2cd22c50d0a2",
  "productndc": "70842-112",
  "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 XL",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019962",
  "marketing_category": "NDA",
  "nonproprietary_name": "Metoprolol Succinate",
  "start_marketing_date": "20230703",
  "active_numerator_strength": "100"
}

Related drugs

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