Alosetron Hydrochloride

Product NDC: 45963-479
11-digit product format: 459630479
Labeler code: 45963
Product ID: 45963-479_963590cd-862a-cf1d-e053-2a95a90af4c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alosetron hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: NDA021107
Marketing category: NDA
Marketing start: 2015-05-26
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

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	45963-479		D	Discontinued by firm		2026-10-02
excluded package	package	45963-479	45963-479-03	D	Discontinued by firm		2026-10-02

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.

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 · 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021107-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021107-002	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45963-479-03	EA - Each	45963-479	9a39d7f1-9901-4227-9ba0-b976b5023b08	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
alosetron hydrochloride	ACTIVE INGREDIENT	2F5R1A46YW	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	4
alosetron	ACTIVE MOIETY	13Z9HTH115	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	4
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	4
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	4
indigotindisulfonate sodium	INACTIVE INGREDIENT	D3741U8K7L	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	4
lactose	INACTIVE INGREDIENT	J2B2A4N98G	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	4
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	4
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	4
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	4
triacetin	INACTIVE INGREDIENT	XHX3C3X673	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45963-479	ALOSETRON HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]	11	Legacy NDC	20241215_969429cb-60b9-4a9c-be60-dd01994431b2.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45963-479-03	45963047903	1 BOTTLE in 1 CARTON (45963-479-03) > 30 TABLET in 1 BOTTLE	1 bottle	2015-05-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alosetron Hydrochloride	Actavis Pharma, Inc. \| Sebela Pharmaceuticals Inc. \| Patheon Inc.	2024-12-12	HUMAN PRESCRIPTION DRUG LABEL	11