🇺🇸
United States · US · US:65162-576_ef9469b2-7a07-48f6-b7be-8a8ae57f08e4
Calcitriol
In shortageOrange BookUNIISPLATC A11CC04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeA11CC04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11651625760330 CAPSULE in 1 BOTTLE (65162-576-03)
- ndc116516257610100 CAPSULE in 1 BOTTLE (65162-576-10)
- ndc116516257625250 CAPSULE in 1 BOTTLE (65162-576-25)
Annotations
UNII (FDA Substance ID)
FXC9231JVH
CALCITRIOL
RxCUI 1894
Orange Book
A203289
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Calcitriol Capsule
Raw payload (JSON)
{
"unii": {
"unii": "FXC9231JVH",
"rxcui": "1894",
"inchikey": "GMRQFYUYWCNGIN-NKMMMXOESA-N",
"display_name": "CALCITRIOL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"bdb9c0d4-bdb3-4174-a4d9-55c423f38476": {
"match": "brand_token",
"title": "CALCITRIOL SOLUTION [ANI PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2026-05-15"
}
},
"productid": "65162-576_ef9469b2-7a07-48f6-b7be-8a8ae57f08e4",
"productndc": "65162-576",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "203289",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MCG",
"product_no": "001",
"approval_date": "Jun 14, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.25MCG",
"product_no": "002",
"approval_date": "Jun 14, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CALCITRIOL",
"shortage_reason": "Calcitriol Capsule",
"shortage_status": "current",
"proprietary_name": "Calcitriol",
"active_ingred_unit": "ug/1",
"application_number": "ANDA203289",
"marketing_category": "ANDA",
"nonproprietary_name": "Calcitriol",
"start_marketing_date": "20170618",
"active_numerator_strength": ".5"
}Related drugs
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