Home NDC 54092-063 Agrylin
Product NDC 54092-063
11-digit product format 540920063
Labeler code 54092
Product ID 54092-063_80829f8c-c5ee-4e37-b5af-1b0e4e4dd5bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name anagrelide hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA020333
Marketing category NDA
Marketing start 1997-03-14
Substance ANAGRELIDE HYDROCHLORIDE ANHYDROUS
Active strength .5 mg/1
Pharmacologic classes Decreased Platelet Production [PE], Phosphodiesterase 3 Inhibitors [MoA], Platelet-reducing Agent [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020333-001 AGRYLIN ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 N020333-002 AGRYLIN ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020333-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020333-002 AGRYLIN EQ 1MG BASE CAPSULE / ORAL RLD 1997-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020333-002 AGRYLIN EQ 1MG BASE CAPSULE / ORAL RLD 1997-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE / ORAL RLD 1997-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1997-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020333-001 AGRYLIN EQ 0.5MG BASE CAPSULE / ORAL AB 1997-03-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020333-002 AGRYLIN EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE / ORAL RLD 1997-03-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Agrylin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANAGRELIDE HYDROCHLORIDE ANHYDROUS .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VNS4435G39 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 597850 Internal RxNorm lookup 597857 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54092-063-01 Agrylin 100 in 1 BOTTLE CAPSULE 100 43
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54092-063 AGRYLIN (ANAGRELIDE HYDROCHLORIDE) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.] 42 Current NDC, Legacy NDC, 1 package rows 20250305_cb960074-99c1-4a73-941f-f0644a7ec219.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Agrylin ANAGRELIDE HYDROCHLORIDE Takeda Pharmaceuticals America, Inc. cb960074-99c1-4a73-941f-f0644a7ec219 2026-04-08 Warnings, Adverse reactions Exact identifier application applno (NDA): 020333 application number: NDA020333 ndc (product): 54092-063
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54092-063-01 54092006301 100 CAPSULE in 1 BOTTLE (54092-063-01) 100 capsule 1997-03-14 0000-00-00 No No Current