Phytonadione

Orange BookUNIISPLATC B02BA01

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

Identification

ManufacturerCipla USA Inc.

CountryUS (United States)

ATC codeB02BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6909770896
10 VIAL in 1 CARTON (69097-708-96) / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

A034SE7857

PHYTONADIONE

RxCUI 11258

Orange Book

A214596

AB2

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": "69097-708_b3dd9cac-1295-48b6-b9b1-48d36cb732b9",
  "productndc": "69097-708",
  "dosage_form": "INJECTION, EMULSION",
  "orange_book": {
    "appl_no": "214596",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB2",
        "strength": "1MG/0.5ML",
        "product_no": "001",
        "approval_date": "Apr 22, 2022"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "10MG/ML",
        "product_no": "002",
        "approval_date": "Apr 22, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHYTONADIONE",
  "proprietary_name": "Phytonadione",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA214596",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phytonadione",
  "start_marketing_date": "20220427",
  "active_numerator_strength": "10"
}

Related drugs

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