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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

  • ndc11
    5409206301
    100 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        "strength": "EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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

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