Phytonadione

Orange BookUNIISPLATC B02BA01

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeB02BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521963501
2 TRAY in 1 CARTON (65219-635-01) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65219-635-00) / 1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

A034SE7857

PHYTONADIONE

RxCUI 11258

Orange Book

A219212

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": {
    "a4b394e7-b766-824e-a8bf-f56808de76e1": {
      "match": "brand_token",
      "title": "PHYTONADIONE INJECTION, EMULSION [XIROMED LLC]",
      "spl_version": "2",
      "published_date": "2026-04-09"
    }
  },
  "productid": "65219-635_02a39690-38e6-42e9-9897-391c2df9e07e",
  "productndc": "65219-635",
  "dosage_form": "INJECTION, EMULSION",
  "orange_book": {
    "appl_no": "219212",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Apr 17, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHYTONADIONE",
  "proprietary_name": "Phytonadione",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA219212",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phytonadione",
  "start_marketing_date": "20250510",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code B02BA01.

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