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United States · US · US:42291-566_487102e3-f317-836b-e063-6394a90a4438

Phytonadione

Orange BookUNIISPLATC B02BA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAvKARE
CountryUS (United States)
ATC codeB02BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4229156630
    1 BOTTLE in 1 BOX (42291-566-30) / 30 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
A034SE7857
PHYTONADIONE
RxCUI 11258
Orange Book
A209373
AB
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": "ORAL",
  "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": "42291-566_487102e3-f317-836b-e063-6394a90a4438",
  "productndc": "42291-566",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209373",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 11, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHYTONADIONE",
  "proprietary_name": "Phytonadione",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209373",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phytonadione",
  "start_marketing_date": "20230907",
  "active_numerator_strength": "5"
}

Related drugs

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