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United States · US · US:69097-999_82b768e9-502a-4b78-8200-c6bc4d0d76b1

Phytonadione

Orange BookUNIISPLATC B02BA01

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

Identification

ManufacturerCipla USA., Inc.
CountryUS (United States)
ATC codeB02BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6909799902
    30 TABLET in 1 BOTTLE (69097-999-02)
  • ndc11
    6909799907
    100 TABLET in 1 BOTTLE (69097-999-07)

Annotations

UNII (FDA Substance ID)
A034SE7857
PHYTONADIONE
RxCUI 11258
Orange Book
A213329
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": "69097-999_82b768e9-502a-4b78-8200-c6bc4d0d76b1",
  "productndc": "69097-999",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213329",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jul 28, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PHYTONADIONE",
  "proprietary_name": "Phytonadione",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213329",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Phytonadione",
  "start_marketing_date": "20231201",
  "active_numerator_strength": "5"
}

Related drugs

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