Doxercalciferol

In shortageOrange BookUNIISPLATC H05BX03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerChartwell RX, LLC

CountryUS (United States)

ATC codeH05BX03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6213545030
30 CAPSULE in 1 BOTTLE (62135-450-30)

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": "62135-450_241fa54b-26c7-a31f-e063-6394a90a7a78",
  "productndc": "62135-450",
  "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": ".5"
}

Related drugs

Other records sharing ATC code H05BX03.

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