Home NDC 54766-895 LOTRONEX
Product NDC 54766-895
11-digit product format 547660895
Labeler code 54766
Product ID 54766-895_87fd4e30-01d6-6ab3-e053-2995a90a522f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alosetron hydrochloride
Dosage form TABLET
Route ORAL
Labeler Sebela Pharmaceuticals Inc.
Application NDA021107
Marketing category NDA
Marketing start 2016-07-11
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 2020-12-31
Current FDA listing Historical FDA.report record 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 N021107-001 LOTRONEX ALOSETRON HYDROCHLORIDE EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 N021107-002 LOTRONEX ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23
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 · 84 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 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base LOTRONEX
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259306 Internal RxNorm lookup 261362 Internal RxNorm lookup 403975 Internal RxNorm lookup 540181 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54766-895 LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [SEBELA PHARMACEUTICALS INC.] 4 Legacy NDC 20190507_35cbb9d5-639b-207a-e054-00144ff88e88.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54766-895-03 54766089503 30 TABLET in 1 BOTTLE (54766-895-03) 30 tablet 2016-07-11 0000-00-00 No No Current