Home NDC 65162-248 Alosetron Hydrochloride
Product NDC 65162-248
11-digit product format 651620248
Labeler code 65162
Product ID 65162-248_c13f2cbc-86c6-4f24-8933-7219f6aa34bd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alosetron Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA206647
Marketing category ANDA
Marketing start 2017-01-02
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A206647-001 ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 A206647-002 ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22
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 · 86 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 2026-09-14 22:38:34 2026-08 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206647-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2016-12-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206647-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2016-12-22 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Alosetron Hydrochloride
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259306 Internal RxNorm lookup 403975 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 65162-248-03 Alosetron Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 18 65162-248-50 Alosetron Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-248 ALOSETRON HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] 18 Current NDC, Legacy NDC, 2 package rows 20241025_ba94ab71-11d7-4ce1-9b21-0b8c6a39e993.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 Marketing start Marketing end Sample Exclude flag Status 65162-248-03 65162024803 30 TABLET, FILM COATED in 1 BOTTLE (65162-248-03) 2017-01-02 0000-00-00 No No Current 65162-248-50 65162024850 500 TABLET, FILM COATED in 1 BOTTLE (65162-248-50) 2017-01-02 0000-00-00 No No Current