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United States · US · US:71288-802_76c7152a-bbff-478d-9a21-a67e1411c61b

Doxercalciferol

In shortageOrange BookUNIISPLATC H05BX03

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeH05BX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7128880204
    25 VIAL, MULTI-DOSE in 1 CARTON (71288-802-04) / 2 mL in 1 VIAL, MULTI-DOSE (71288-802-02)

Annotations

UNII (FDA Substance ID)
3DIZ9LF5Y9
DOXERCALCIFEROL
RxCUI 11516
Orange Book
A211670
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": "71288-802_76c7152a-bbff-478d-9a21-a67e1411c61b",
  "productndc": "71288-802",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "211670",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "4MCG/2ML (2MCG/ML)",
        "product_no": "001",
        "approval_date": "Feb 7, 2020"
      }
    ],
    "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": "ANDA211670",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxercalciferol",
  "start_marketing_date": "20200211",
  "active_numerator_strength": "4"
}

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