phytonadione

Orange BookUNIISPLATC B02BA01

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeB02BA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7012116827
10 TRAY in 1 CARTON (70121-1682-7) / 1 SYRINGE, GLASS in 1 TRAY (70121-1682-1) / .5 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

A034SE7857

PHYTONADIONE

RxCUI 11258

Orange Book

A216601

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": "70121-1682_a2f87d42-33cd-4706-bd3c-8b15c8095617",
  "productndc": "70121-1682",
  "dosage_form": "INJECTION, EMULSION",
  "orange_book": {
    "appl_no": "216601",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "1MG/0.5ML",
        "product_no": "001",
        "approval_date": "Nov 4, 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": "ANDA216601",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PHYTONADIONE",
  "start_marketing_date": "20251104",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code B02BA01.

Access this data programmatically

Query phytonadione and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs