ZELNORM

Product NDC: 0525-0971
Requested package NDC: 0525-0971-60
11-digit product format: 005250971
Labeler code: 0525
Product ID: 0525-0971_2159f794-0f55-48b5-833c-ff1db7567bed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tegaserod
Dosage form: TABLET
Route: ORAL
Labeler: Alfasigma USA, Inc.
Application: NDA021200
Marketing category: NDA
Marketing start: 2019-08-01
Marketing end: 0000-00-00
Substance: TEGASEROD
Active strength: 6 mg/1
Pharmacologic classes: Serotonin 4 Receptor Antagonists [MoA],Serotonin-4 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0525-0971	0525-0971-60	I	Inactivated by FDA		2026-10-12

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
N021200-001	ZELNORM	TEGASEROD MALEATE	EQ 2MG BASE	TABLET / ORAL		RLD	2002-07-24
N021200-002	ZELNORM	TEGASEROD MALEATE	EQ 6MG BASE	TABLET / ORAL		RLD	2002-07-24

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD	2002-07-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD, RS	2002-07-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD, RS	2002-07-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD, RS	2002-07-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021200-001	ZELNORM	EQ 2MG BASE	TABLET / ORAL	RLD	2002-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021200-002	ZELNORM	EQ 6MG BASE	TABLET / ORAL	RLD, RS	2002-07-24	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0525-0971-10	2022-01-28	C162847	48780-1	d6a99b39-7466-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use ZELNORM ™ safely and effectively. See full prescribing information for ZELNORM ™ . ZELNORM ™ (tegaserod) tablets, for oral use Initial U.S. Approval: 2002
0525-0971-30	2022-01-28	C162847	48780-1	d6a99b39-7466-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use ZELNORM ™ safely and effectively. See full prescribing information for ZELNORM ™ . ZELNORM ™ (tegaserod) tablets, for oral use Initial U.S. Approval: 2002
0525-0971-60	2022-01-28	C162847	48780-1	d6a99b39-7466-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use ZELNORM ™ safely and effectively. See full prescribing information for ZELNORM ™ . ZELNORM ™ (tegaserod) tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0525-0971-10	ZELNORM	1 in 1 CARTON	TABLET	1	4
0525-0971-10	ZELNORM	10 in 1 BLISTER PACK	TABLET	10	4
0525-0971-30	ZELNORM	3 in 1 CARTON	TABLET	3	4
0525-0971-30	ZELNORM	10 in 1 BLISTER PACK	TABLET	10	4
0525-0971-60	ZELNORM	6 in 1 CARTON	TABLET	6	4
0525-0971-60	ZELNORM	10 in 1 BLISTER PACK	TABLET	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0525-0971-60	EA - Each	0525-0971	373fd99a-d719-404c-a376-ddbab4ca248d	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0525-0971	ZELNORM (TEGASEROD) TABLET [ALFASIGMA USA, INC.]	4	Legacy NDC, 6 package rows	20200605_6a44eefe-fbe8-431c-a418-2571b26aa42e.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
458VC51857	TEGASEROD	145158-71-0	TEGASEROD

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349467	tegaserod maleate 6 MG Oral Tablet	PSN	6a44eefe-fbe8-431c-a418-2571b26aa42e	4
352188	Zelnorm 6 MG Oral Tablet	PSN	6a44eefe-fbe8-431c-a418-2571b26aa42e	4
352188	tegaserod 6 MG Oral Tablet [Zelnorm]	SBD	6a44eefe-fbe8-431c-a418-2571b26aa42e	4
349467	tegaserod 6 MG Oral Tablet	SCD	6a44eefe-fbe8-431c-a418-2571b26aa42e	4
352188	Zelnorm 6 MG Oral Tablet	SY	6a44eefe-fbe8-431c-a418-2571b26aa42e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0525-0971-60	00525097160	6 BLISTER PACK in 1 CARTON (0525-0971-60) > 10 TABLET in 1 BLISTER PACK	6 blister pack	2019-08-01	0000-00-00	No	No	Current