Home NDC 70954-879 Anagrelide
Product NDC 70954-879
11-digit product format 709540879
Labeler code 70954
Product ID 70954-879_56b3959d-4b6b-413f-b753-9d4c20c07466
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Anagrelide
Dosage form CAPSULE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA076811
Marketing category ANDA
Marketing start 2025-11-06
Substance ANAGRELIDE HYDROCHLORIDE
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 2026-12-31
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 A076811-001 ANAGRELIDE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2005-04-18 A076811-002 ANAGRELIDE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2005-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2005-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2005-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2005-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2005-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076811-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL 2005-04-18 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076811-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL 2005-04-18 782e0a99824c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Anagrelide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANAGRELIDE HYDROCHLORIDE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YTM763Y5C8 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 597852 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70954-879-10 Anagrelide 100 in 1 BOTTLE CAPSULE 100 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70954-879-10 70954087910 100 CAPSULE in 1 BOTTLE (70954-879-10) 100 capsule 2025-11-06 No No Current