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United States · US · US:54092-063_80829f8c-c5ee-4e37-b5af-1b0e4e4dd5bd
Agrylin
In shortageOrange BookUNIISPLATC L01XX35
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeL01XX35
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115409206301100 CAPSULE in 1 BOTTLE (54092-063-01)
Annotations
UNII (FDA Substance ID)
VNS4435G39
ANAGRELIDE HYDROCHLORIDE ANHYDROUS
RxCUI 236612
Orange Book
N020333
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Anagrelide Hydrochloride Capsule
Raw payload (JSON)
{
"unii": {
"unii": "VNS4435G39",
"rxcui": "236612",
"inchikey": "TVWRQCIPWUCNMI-UHFFFAOYSA-N",
"display_name": "ANAGRELIDE HYDROCHLORIDE ANHYDROUS",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"cb960074-99c1-4a73-941f-f0644a7ec219": {
"match": "brand_token",
"title": "AGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "43",
"published_date": "2026-04-10"
}
},
"productid": "54092-063_80829f8c-c5ee-4e37-b5af-1b0e4e4dd5bd",
"productndc": "54092-063",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "020333",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 0.5MG BASE",
"product_no": "001",
"approval_date": "Mar 14, 1997"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Mar 14, 1997"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ANAGRELIDE HYDROCHLORIDE ANHYDROUS",
"shortage_reason": "Anagrelide Hydrochloride Capsule",
"shortage_status": "current",
"proprietary_name": "Agrylin",
"active_ingred_unit": "mg/1",
"application_number": "NDA020333",
"marketing_category": "NDA",
"nonproprietary_name": "anagrelide hydrochloride",
"start_marketing_date": "19970314",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code L01XX35.
- DKAnagrelid "Bluefish"Bluefish Pharmaceuticals AB
- PLAnagrelid AurovitasAurovitas Pharma Polska Sp. z o.o.
- FIAnagrelid AvansorAvansor Pharma Oy
- PLAnagrelid NordicNordic Group B.V.
- PLAnagrelid NordicNordic Group B.V.
- PLAnagrelid NordicNordic Group B.V.
- FIAnagrelid OrionOrion Corporation
- BEAnagrelid Sandoz 0.5 mgSandoz
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