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United States · US · US:45963-607_1a467892-817b-4ff8-a58e-b69e0c3462cc

Vinorelbine

Orange BookUNIISPLATC L01CA04

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeL01CA04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4596360755
    1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) / 1 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    4596360756
    1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-56) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
253GQW851Q
VINORELBINE TARTRATE
RxCUI 114527
Orange Book
A078011
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "253GQW851Q",
    "rxcui": "114527",
    "inchikey": "CILBMBUYJCWATM-PYGJLNRPSA-N",
    "display_name": "VINORELBINE TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "10a70995-e04d-4044-b1dc-c9aa27460397": {
      "match": "brand_token",
      "title": "VINORELBINE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]",
      "spl_version": "10",
      "published_date": "2024-09-18"
    }
  },
  "productid": "45963-607_1a467892-817b-4ff8-a58e-b69e0c3462cc",
  "productndc": "45963-607",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "078011",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jul 22, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "VINORELBINE TARTRATE",
  "proprietary_name": "Vinorelbine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078011",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Vinorelbine",
  "start_marketing_date": "20150301",
  "active_numerator_strength": "10"
}

Related drugs

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