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United States · US · US:62135-312_13156e50-28d1-0994-e063-6394a90a16ec

Anagrelide

In shortageOrange BookUNIISPLATC L01XX35

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeL01XX35
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6213531212
    120 CAPSULE in 1 BOTTLE (62135-312-12)

Annotations

UNII (FDA Substance ID)
VNS4435G39
ANAGRELIDE HYDROCHLORIDE ANHYDROUS
RxCUI 236612
Orange Book
A076683
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": {
    "56b3959d-4b6b-413f-b753-9d4c20c07466": {
      "match": "brand_token",
      "title": "ANAGRELIDE CAPSULE [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2025-12-05"
    }
  },
  "productid": "62135-312_13156e50-28d1-0994-e063-6394a90a16ec",
  "productndc": "62135-312",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076683",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 18, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Apr 18, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ANAGRELIDE HYDROCHLORIDE ANHYDROUS",
  "shortage_reason": "Anagrelide Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "Anagrelide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076683",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Anagrelide",
  "start_marketing_date": "20050418",
  "active_numerator_strength": ".5"
}

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