Phytonadione

Orange BookUNIISPLATC B02BA01

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

Identification

ManufacturerSagent Pharmaceuticals

CountryUS (United States)

ATC codeB02BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2502150570
10 SYRINGE in 1 CARTON (25021-505-70) / .5 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

A034SE7857

PHYTONADIONE

RxCUI 11258

Orange Book

A216444

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": "25021-505_ba507639-69c8-4451-ac5c-b5bc64f297ca",
  "productndc": "25021-505",
  "dosage_form": "INJECTION, EMULSION",
  "orange_book": {
    "appl_no": "216444",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "1MG/0.5ML",
        "product_no": "001",
        "approval_date": "Sep 8, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHYTONADIONE",
  "proprietary_name": "Phytonadione",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "ANDA216444",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phytonadione",
  "start_marketing_date": "20260201",
  "active_numerator_strength": "1"
}

Related drugs

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