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United States · US · US:25021-313_753b9d9d-f4a7-4604-8bfe-20d0a811883a

Milrinone Lactate in Dextrose

Orange BookUNIISPLATC C01CE02

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

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeC01CE02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2502131382
    10 BAG in 1 CARTON (25021-313-82) / 100 mL in 1 BAG
  • ndc11
    2502131387
    10 BAG in 1 CARTON (25021-313-87) / 200 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
9K8XR81MO8
MILRINONE LACTATE
RxCUI 155120
Orange Book
A213585
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9K8XR81MO8",
    "rxcui": "155120",
    "inchikey": "VWUPWEAFIOQCGF-UHFFFAOYSA-N",
    "display_name": "MILRINONE LACTATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "4c2f052b-7ba2-4122-a50b-37ef2a834d61": {
      "match": "brand_token",
      "title": "MILRINONE LACTATE IN DEXTROSE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "8",
      "published_date": "2026-05-20"
    }
  },
  "productid": "25021-313_753b9d9d-f4a7-4604-8bfe-20d0a811883a",
  "productndc": "25021-313",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "213585",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jul 16, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Jul 16, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MILRINONE LACTATE",
  "proprietary_name": "Milrinone Lactate in Dextrose",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA213585",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Milrinone Lactate",
  "start_marketing_date": "20210115",
  "active_numerator_strength": ".2"
}

Related drugs

Other records sharing ATC code C01CE02.

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