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United States · US · US:68083-300_db27a30b-8264-4248-b83e-b6ba0feafbf0

Doxercalciferol

In shortageOrange BookUNIISPLATC H05BX03

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

Identification

ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeH05BX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808330050
    50 VIAL, SINGLE-DOSE in 1 CARTON (68083-300-50) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-300-01)

Annotations

UNII (FDA Substance ID)
3DIZ9LF5Y9
DOXERCALCIFEROL
RxCUI 11516
Orange Book
A210452
AP
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": "68083-300_db27a30b-8264-4248-b83e-b6ba0feafbf0",
  "productndc": "68083-300",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210452",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4MCG/2ML (2MCG/ML)",
        "product_no": "001",
        "approval_date": "Sep 26, 2019"
      }
    ],
    "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": "ANDA210452",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxercalciferol",
  "start_marketing_date": "20190926",
  "active_numerator_strength": "4"
}

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