Home NDC 83107-013 LOTRONEX
Product NDC 83107-013
11-digit product format 831070013
Labeler code 83107
Product ID 83107-013_4db1d464-27cc-80a9-e063-6394a90ade00
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alosetron hydrochloride
Dosage form TABLET
Route ORAL
Labeler Legacy Pharma USA Inc.
Application NDA021107
Marketing category NDA
Marketing start 2026-01-01
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 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 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 · 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 N021107-001 LOTRONEX EQ 1MG BASE TABLET / ORAL AB RLD, RS 2000-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021107-002 LOTRONEX EQ 0.5MG BASE TABLET / ORAL AB RLD 2003-12-23 84e616aacf4f…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…
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 LOTRONEX
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 · 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83107-013-30 LOTRONEX 30 in 1 BOTTLE TABLET 30 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83107-013-30 83107001330 30 TABLET in 1 BOTTLE (83107-013-30) 30 tablet 2026-01-01 No No Current