agrylin

Generic: anagrelide hydrochloride

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name agrylin
Generic Name anagrelide hydrochloride
Labeler takeda pharmaceuticals america, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

anagrelide hydrochloride anhydrous .5 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-063
Product ID 54092-063_06f9dfa4-c90a-4636-b3b1-79b488815bb3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020333
Listing Expiration 2026-12-31
Marketing Start 1997-03-14

Pharmacologic Class

Classes
decreased platelet production [pe] phosphodiesterase 3 inhibitors [moa] platelet-reducing agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54092063
Hyphenated Format 54092-063

Supplemental Identifiers

RxCUI
597850 597857
UPC
0354092063017
UNII
VNS4435G39

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name agrylin (source: ndc)
Generic Name anagrelide hydrochloride (source: ndc)
Application Number NDA020333 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (54092-063-01)
source: ndc

Packages (1)

54092-063-01 100 CAPSULE in 1 BOTTLE (54092-063-01)

Ingredients (1)

anagrelide hydrochloride anhydrous (.5 mg/1)

Linked Drug Pages (1)

Agrylin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "06f9dfa4-c90a-4636-b3b1-79b488815bb3", "openfda": {"upc": ["0354092063017"], "unii": ["VNS4435G39"], "rxcui": ["597850", "597857"], "spl_set_id": ["cb960074-99c1-4a73-941f-f0644a7ec219"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (54092-063-01)", "package_ndc": "54092-063-01", "marketing_start_date": "19970314"}], "brand_name": "Agrylin", "product_id": "54092-063_06f9dfa4-c90a-4636-b3b1-79b488815bb3", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Platelet Production [PE]", "Phosphodiesterase 3 Inhibitors [MoA]", "Platelet-reducing Agent [EPC]"], "product_ndc": "54092-063", "generic_name": "anagrelide hydrochloride", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Agrylin", "active_ingredients": [{"name": "ANAGRELIDE HYDROCHLORIDE ANHYDROUS", "strength": ".5 mg/1"}], "application_number": "NDA020333", "marketing_category": "NDA", "marketing_start_date": "19970314", "listing_expiration_date": "20261231"}