Home NDC 63629-2517 Alosetron
Product NDC 63629-2517
11-digit product format 636292517
Labeler code 63629
Product ID 63629-2517_6be48a5b-38ea-45da-b4ad-03ad595e4744
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alosetron
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA213614
Marketing category ANDA
Marketing start 2020-09-14
Substance ALOSETRON HYDROCHLORIDE
Active strength .5 mg/1
Pharmacologic classes Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-2517-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63629-2517-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63629-2517-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63629-2517-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63629-2517-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63629-2517-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63629-2517-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63629-2517-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63629-2517-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63629-2517-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63629-2517-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63629-2517-1 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 63629-2517-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 63629-2517-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 63629-2517-1 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A213614-001 ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 A213614-002 ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09
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 2 · 76 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 2026-08-18 06:07:40 2026-07 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213614-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2020-09-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213614-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2020-09-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Alosetron
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALOSETRON 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 2F5R1A46YW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 403975 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 63629-2517-1 Alosetron 30 in 1 BOTTLE TABLET 30 102
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2517 ALOSETRON TABLET [BRYANT RANCH PREPACK] 101 Current NDC, Legacy NDC, 1 package rows 20220504_da94d161-0bf0-48fe-90f4-8e38ae18e1ca.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 · 3 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 63629-2517-1 63629251701 30 TABLET in 1 BOTTLE (63629-2517-1) 30 tablet 2022-04-29 0000-00-00 No No Current