🇺🇸
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
- ndc11680833005050 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"
}Related drugs
Other records sharing ATC code H05BX03.
- 🇺🇸DoxercalciferolREMEDYREPACK INC.
- 🇺🇸DoxercalciferolEugia US LLC
- 🇺🇸DoxercalciferolHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- 🇺🇸DoxercalciferolChartwell RX, LLC
- 🇺🇸DoxercalciferolHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- 🇺🇸DoxercalciferolChartwell RX, LLC
- 🇺🇸DoxercalciferolEugia US LLC
- 🇺🇸DoxercalciferolAlembic Pharmaceuticals Inc.
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