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United States · US · US:23155-539_861e8a97-2618-40cd-b2bd-6b21cd9a38db

Doxercalciferol

In shortageOrange BookUNIISPLATC H05BX03

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

Identification

ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeH05BX03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2315553925
    50 CAPSULE in 1 BOTTLE (23155-539-25)

Annotations

UNII (FDA Substance ID)
3DIZ9LF5Y9
DOXERCALCIFEROL
RxCUI 11516
Orange Book
A205360
ABABAB
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": "ORAL",
  "spl_meta": {
    "943a3f95-842c-455f-9050-3d1c3971c6f8": {
      "match": "brand_token",
      "title": "DOXERCALCIFEROL CAPSULE [REMEDYREPACK INC.]",
      "spl_version": "1",
      "published_date": "2026-04-30"
    }
  },
  "productid": "23155-539_861e8a97-2618-40cd-b2bd-6b21cd9a38db",
  "productndc": "23155-539",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "205360",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5MCG",
        "product_no": "001",
        "approval_date": "Sep 15, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1MCG",
        "product_no": "002",
        "approval_date": "Sep 15, 2020"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MCG",
        "product_no": "003",
        "approval_date": "Sep 15, 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/1",
  "application_number": "ANDA205360",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Doxercalciferol",
  "start_marketing_date": "20201031",
  "active_numerator_strength": "1"
}

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