SEREVENT

Product NDC: 68258-8961
11-digit product format: 682588961
Labeler code: 68258
Product ID: 68258-8961_198f20a2-218e-4a0f-a4c1-ae7c3b62e1c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: salmeterol xinafoate
Dosage form: POWDER, METERED
Route: ORAL; RESPIRATORY (INHALATION)
Labeler: Dispensing Solutions, Inc.
Application: NDA020692
Marketing category: NDA
Marketing start: 1997-11-25
Marketing end: 0000-00-00
Substance: SALMETEROL XINAFOATE
Active strength: 50 ug/1
Pharmacologic classes: Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [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	68258-8961		I	Inactivated by FDA		2026-08-10
excluded package	package	68258-8961	68258-8961-6	I	Inactivated by FDA		2026-08-10

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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68258-8961-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68258-8961-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68258-8961-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68258-8961-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68258-8961-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68258-8961-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68258-8961-6	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68258-8961-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68258-8961-6	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68258-8961-6	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68258-8961-6	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68258-8961-6	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68258-8961-6	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68258-8961-6	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68258-8961-6	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68258-8961-6	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68258-8961-6	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68258-8961-6	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68258-8961-6	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68258-8961-6	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68258-8961-6	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68258-8961-6	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020692-001	SEREVENT	SALMETEROL XINAFOATE	EQ 0.05MG BASE/INH	POWDER / INHALATION		RLD, RS	1997-09-19

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020692-001	SEREVENT	EQ 0.05MG BASE/INH	POWDER / INHALATION	RLD, RS	1997-09-19	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a31ad3df-8021-2ea1-94eb-0fe2f49b7729	Product name	4	20220719
0e5a25a6-9f05-44b5-8449-aa63e59f7202	Product name	1	20170426
811691fa-281f-6d95-fb49-e2337fb2e146	Product name	1	20140508
aef26912-037b-9a4e-db49-225ef6dfd8f1	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-8961-6	2019-11-13	C162847	48780-1	97449f38-d15d-f6ea-e053-dbdaa90aa703	These highlights do not include all the information needed to use SEREVENT DISKUS safely and effectively. See full prescribing information for SEREVENT DISKUS. SEREVENT DISKUS (salmeterol xinafoate inhalation powder) FOR ORAL INHALATION Initial U.S. Approval: 1994

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-8961-6	SEREVENTDISKUS	60 in 1 INHALER	POWDER, METERED	60		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALMETEROL XINAFOATE	ACTIVE INGREDIENT	6EW8Q962A5	SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.]	2
SALMETEROL	ACTIVE MOIETY	2I4BC502BT	SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-8961	SEREVENT DISKUS (SALMETEROL XINAFOATE) POWDER, METERED [DISPENSING SOLUTIONS, INC.]	2	Legacy NDC, 1 package rows	20120928_c4925b2c-bde1-45fd-8109-dc75bee3b7a3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SEREVENT DISKUS	SALMETEROL XINAFOATE	GlaxoSmithKline LLC	12d9728e-6b5c-4aee-bfb0-745e542ed2e4	2022-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020692 application number: NDA020692

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6EW8Q962A5	SALMETEROL XINAFOATE	94749-08-3	SALMETEROL XINAFOATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866048	salmeterol 50 MCG/INHAL Dry Powder Inhaler, 60 Bisters	PSN	c4925b2c-bde1-45fd-8109-dc75bee3b7a3	2
866049	Serevent Diskus 50 MCG/INHAL Dry Powder Inhaler, 60 Blisters	PSN	c4925b2c-bde1-45fd-8109-dc75bee3b7a3	2
866049	60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler [Serevent]	SBD	c4925b2c-bde1-45fd-8109-dc75bee3b7a3	2
866048	60 ACTUAT salmeterol 0.05 MG/ACTUAT Dry Powder Inhaler	SCD	c4925b2c-bde1-45fd-8109-dc75bee3b7a3	2
866049	60 ACTUAT Serevent 0.05 MG/ACTUAT Dry Powder Inhaler	SY	c4925b2c-bde1-45fd-8109-dc75bee3b7a3	2
866048	salmeterol 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 Actuat	SY	c4925b2c-bde1-45fd-8109-dc75bee3b7a3	2
866049	Serevent Diskus 50 MCG (salmeterol xinafoate 72.5 MCG) per ACTUAT Dry Powder Inhaler, 60 ACTUAT	SY	c4925b2c-bde1-45fd-8109-dc75bee3b7a3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-8961-6	68258896106	60 in 1 INHALER	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SEREVENT DISKUS - Dispensing Solutions, Inc. \| PSS World Medical, Inc.	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-09-27	HUMAN PRESCRIPTION DRUG LABEL	2