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United States · US · US:55150-359_211361e9-87ad-476a-af8f-8b887c3b6c4e

Doxercalciferol

In shortageOrange BookUNIISPLATC H05BX03

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

Identification

ManufacturerEugia US LLC
CountryUS (United States)
ATC codeH05BX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515035950
    50 CARTON in 1 CARTON (55150-359-50) / 1 VIAL, MULTI-DOSE in 1 CARTON (55150-359-01) / 2 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
3DIZ9LF5Y9
DOXERCALCIFEROL
RxCUI 11516
Orange Book
A213717
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Doxercalciferol Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "3DIZ9LF5Y9",
    "rxcui": "11516",
    "inchikey": "HKXBNHCUPKIYDM-CGMHZMFXSA-N",
    "display_name": "DOXERCALCIFEROL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "943a3f95-842c-455f-9050-3d1c3971c6f8": {
      "match": "brand_token",
      "title": "DOXERCALCIFEROL CAPSULE [REMEDYREPACK INC.]",
      "spl_version": "1",
      "published_date": "2026-04-30"
    }
  },
  "productid": "55150-359_211361e9-87ad-476a-af8f-8b887c3b6c4e",
  "productndc": "55150-359",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "213717",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "2MCG/ML (2MCG/ML)",
        "product_no": "001",
        "approval_date": "Jan 24, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "4MCG/2ML (2MCG/ML)",
        "product_no": "002",
        "approval_date": "Jan 24, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXERCALCIFEROL",
  "shortage_reason": "Doxercalciferol Injection",
  "shortage_status": "current",
  "proprietary_name": "Doxercalciferol",
  "active_ingred_unit": "ug/2mL",
  "application_number": "ANDA213717",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxercalciferol",
  "start_marketing_date": "20220124",
  "active_numerator_strength": "4"
}

Related drugs

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