Home NDC 0054-0296 Alosetron Hydrochloride
Product NDC 0054-0296
11-digit product format 000540296
Labeler code 0054
Product ID 0054-0296_ca09da58-08c8-4520-b2a7-f33d3feaa15f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alosetron hydrochloride
Dosage form TABLET
Route ORAL
Labeler West-Ward Pharmaceuticals Corp.
Application ANDA200652
Marketing category ANDA
Marketing start 2013-07-15
Marketing end 0000-00-00
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 2022-12-31
Current FDA listing Historical FDA.report record
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A200652-001 ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 A200652-002 ALOSETRON HYDROCHLORIDE ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04
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 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL 2015-05-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL 2015-05-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2015-05-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2015-05-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2015-05-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2015-05-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2015-05-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2015-05-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200652-001 ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB 2015-05-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200652-002 ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB 2015-05-04 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALOSETRON HYDROCHLORIDE ACTIVE INGREDIENT 2F5R1A46YW ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] 1 ALOSETRON ACTIVE MOIETY 13Z9HTH115 ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ALOSETRON HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0054-0296-13 00054029613 30 TABLET in 1 BOTTLE (0054-0296-13) 30 tablet 2015-05-04 0000-00-00 No No Current 0054-0296-25 00054029625 100 TABLET in 1 BOTTLE (0054-0296-25) 100 tablet 2015-05-04 0000-00-00 No No Current