Home NDC 63629-2518 Alosetron
Product NDC 63629-2518
11-digit product format 636292518
Labeler code 63629
Product ID 63629-2518_cd337c95-1e5a-4dfa-84f7-e668c93d8565
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 1 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 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 1 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 259306 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 63629-2518-1 Alosetron 30 in 1 BOTTLE TABLET 30 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2518 ALOSETRON TABLET [BRYANT RANCH PREPACK] 102 Current NDC, Legacy NDC, 1 package rows 20240112_38f5341f-5ae3-46bf-8bfc-30dff2068477.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 63629-2518-1 63629251801 30 TABLET in 1 BOTTLE (63629-2518-1) 30 tablet 2021-03-29 0000-00-00 No No Current