LOTRONEX

Product NDC: 65483-895
11-digit product format: 654830895
Labeler code: 65483
Product ID: 65483-895_800b0802-c4e6-409f-adbc-a985d1fca2a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alosetron hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Prometheus Laboratories Inc.
Application: NDA021107
Marketing category: NDA
Marketing start: 2009-02-09
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: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65483-895		I	Inactivated by FDA		2026-09-09
excluded package	package	65483-895	65483-895-03	I	Inactivated by FDA		2026-09-09

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65483-895-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65483-895-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65483-895-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65483-895-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65483-895-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65483-895-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65483-895-03	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65483-895-03	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65483-895-03	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65483-895-03	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65483-895-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65483-895-03	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	65483-895-03	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	65483-895-03	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	65483-895-03	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65483-895-03	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65483-895-03	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65483-895-03	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65483-895-03	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65483-895-03	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65483-895-03	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65483-895-03	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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.

Application-product, TE code table
Application-product	TE code
N021107-001	AB
N021107-002	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021107-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021107-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021107-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021107-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021107-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021107-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021107-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021107-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021107-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021107-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021107-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021107-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021107-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021107-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021107-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021107-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021107-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021107-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021107-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021107-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021107-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021107-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021107-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021107-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021107-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021107-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021107-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021107-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021107-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021107-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021107-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021107-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021107-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021107-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021107-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021107-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021107-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021107-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021107-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021107-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
9a726e57-9bfe-419e-b2fb-835ed905be3d	Product name	6	20210511

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65483-895-03	2020-01-31	C162847	48780-1	9d75b9d0-8095-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use LOTRONEX safely and effectively. See full prescribing information for LOTRONEX. LOTRONEX (alosetron hydrochloride) Tablets Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65483-895-03	LOTRONEX	30 in 1 BOTTLE	TABLET	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65483-895-03	EA - Each	65483-895	53579187-d54c-463f-80f3-08e826495f19	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
alosetron hydrochloride	ACTIVE INGREDIENT	2F5R1A46YW	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	9
alosetron	ACTIVE MOIETY	13Z9HTH115	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	9
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	9
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	9
indigotindisulfonate sodium	INACTIVE INGREDIENT	D3741U8K7L	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	9
lactose	INACTIVE INGREDIENT	J2B2A4N98G	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	9
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	9
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	9
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	9
triacetin	INACTIVE INGREDIENT	XHX3C3X673	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65483-895	LOTRONEX (ALOSETRON HYDROCHLORIDE) TABLET [PROMETHEUS LABORATORIES INC.]	10	Legacy NDC, 1 package rows	20160121_526ba44c-a476-4675-a63c-4d0a72b723f5.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LOTRONEX	ALOSETRON HYDROCHLORIDE	Sebela Pharmaceuticals Inc.	35cbb9d5-639b-207a-e054-00144ff88e88	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021107 application number: NDA021107
LOTRONEX	ALOSETRON HYDROCHLORIDE	Legacy Pharma USA Inc.	c216e967-436f-475a-8e6a-2ad11adc63af	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021107 application number: NDA021107

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2F5R1A46YW	ALOSETRON HYDROCHLORIDE	122852-69-1	ALOSETRON HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
403975	alosetron HCl 0.5 MG Oral Tablet	PSN	526ba44c-a476-4675-a63c-4d0a72b723f5	10
259306	alosetron HCl 1 MG Oral Tablet	PSN	526ba44c-a476-4675-a63c-4d0a72b723f5	10
540181	Lotronex 0.5 MG Oral Tablet	PSN	526ba44c-a476-4675-a63c-4d0a72b723f5	10
261362	Lotronex 1 MG Oral Tablet	PSN	526ba44c-a476-4675-a63c-4d0a72b723f5	10
540181	alosetron 0.5 MG Oral Tablet [Lotronex]	SBD	526ba44c-a476-4675-a63c-4d0a72b723f5	10
261362	alosetron 1 MG Oral Tablet [Lotronex]	SBD	526ba44c-a476-4675-a63c-4d0a72b723f5	10
403975	alosetron 0.5 MG Oral Tablet	SCD	526ba44c-a476-4675-a63c-4d0a72b723f5	10
259306	alosetron 1 MG Oral Tablet	SCD	526ba44c-a476-4675-a63c-4d0a72b723f5	10
403975	alosetron 0.5 MG (as alosetron HCl 0.562 MG) Oral Tablet	SY	526ba44c-a476-4675-a63c-4d0a72b723f5	10
259306	alosetron 1 MG (as alosetron HCl 1.124 MG) Oral Tablet	SY	526ba44c-a476-4675-a63c-4d0a72b723f5	10
540181	Lotronex 0.5 MG (alosetron hydrochloride 0.562 MG) Oral Tablet	SY	526ba44c-a476-4675-a63c-4d0a72b723f5	10
540181	Lotronex 0.5 MG Oral Tablet	SY	526ba44c-a476-4675-a63c-4d0a72b723f5	10
261362	Lotronex 1 MG (alosetron hydrochloride 1.124 MG) Oral Tablet	SY	526ba44c-a476-4675-a63c-4d0a72b723f5	10
261362	Lotronex 1 MG Oral Tablet	SY	526ba44c-a476-4675-a63c-4d0a72b723f5	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
65483-895-03	65483089503	30 in 1 BOTTLE	Historical