Home NDC 13668-462 anagrelide
Product NDC 13668-462
11-digit product format 136680462
Labeler code 13668
Product ID 13668-462_a049d02a-22e1-4ea2-8c05-50b50cef4362
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name anagrelide
Dosage form CAPSULE
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Application ANDA209151
Marketing category ANDA
Marketing start 2017-06-30
Substance ANAGRELIDE HYDROCHLORIDE ANHYDROUS
Active strength 1 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 A209151-001 ANAGRELIDE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 A209151-002 ANAGRELIDE HYDROCHLORIDE ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30
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 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209151-001 ANAGRELIDE HYDROCHLORIDE EQ 0.5MG BASE CAPSULE / ORAL AB 2017-06-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209151-002 ANAGRELIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL AB 2017-06-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base anagrelide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANAGRELIDE HYDROCHLORIDE ANHYDROUS 1 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 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 13668-462-01 anagrelide 100 in 1 BOTTLE CAPSULE 100 10 13668-462-30 anagrelide 30 in 1 BOTTLE CAPSULE 30 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13668-462 ANAGRELIDE CAPSULE [TORRENT PHARMACEUTICALS LIMITED] 10 Current NDC, Legacy NDC, 2 package rows 20241004_875cc32a-219c-4b6b-802a-98a47cbc9a78.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.
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 13668-462-01 13668046201 100 CAPSULE in 1 BOTTLE (13668-462-01) 100 capsule 2017-06-30 0000-00-00 No No Current 13668-462-30 13668046230 30 CAPSULE in 1 BOTTLE (13668-462-30) 30 capsule 2017-06-30 0000-00-00 No No Current 13668-462-74 13668046274 100 CAPSULE in 1 CARTON (13668-462-74) 100 capsule 2017-06-30 0000-00-00 No No Current