VITAMIN K1 - PHYTONADIONE

Orange BookUNIISPLATC B02BA01

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst

CountryUS (United States)

ATC codeB02BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166215363
25 POUCH in 1 BOX (51662-1536-3) / 1 AMPULE in 1 POUCH (51662-1536-2) / 1 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)

A034SE7857

PHYTONADIONE

RxCUI 11258

Orange Book

A087955

AB1

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "A034SE7857",
    "rxcui": "11258",
    "inchikey": null,
    "display_name": "PHYTONADIONE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "e8808230-2c44-44c6-8cab-8f29b6b34051": {
      "match": "brand_token",
      "title": "VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.]",
      "spl_version": "22",
      "published_date": "2026-05-26"
    }
  },
  "productid": "51662-1536_1034ddca-fc35-505d-e063-6394a90a92c3",
  "productndc": "51662-1536",
  "dosage_form": "INJECTION, EMULSION",
  "orange_book": {
    "appl_no": "087955",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Jul 25, 1983"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHYTONADIONE",
  "proprietary_name": "VITAMIN K1 - PHYTONADIONE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA087955",
  "marketing_category": "ANDA",
  "nonproprietary_name": "VITAMIN K1 - PHYTONADIONE",
  "start_marketing_date": "20210510",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code B02BA01.

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