Anagrelide

In shortageOrange BookUNIISPLATC L01XX35

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerANI Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL01XX35

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7095487910
100 CAPSULE in 1 BOTTLE (70954-879-10)

Annotations

UNII (FDA Substance ID)

YTM763Y5C8

ANAGRELIDE HYDROCHLORIDE

Orange Book

A076811

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Anagrelide Hydrochloride Capsule

Raw payload (JSON)

{
  "unii": {
    "unii": "YTM763Y5C8",
    "rxcui": null,
    "inchikey": "YLFXXKJQBOJJIX-UHFFFAOYSA-N",
    "display_name": "ANAGRELIDE HYDROCHLORIDE",
    "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": "70954-879_56b3959d-4b6b-413f-b753-9d4c20c07466",
  "productndc": "70954-879",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "076811",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Apr 18, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "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",
  "shortage_reason": "Anagrelide Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "Anagrelide",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076811",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Anagrelide",
  "start_marketing_date": "20251106",
  "active_numerator_strength": ".5"
}

Related drugs

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