RELENZA

Product NDC: 68258-3030
11-digit product format: 682583030
Labeler code: 68258
Product ID: 68258-3030_342b7e19-49d6-4d0b-950a-cc00f4b79924
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zanamivir
Dosage form: POWDER
Route: RESPIRATORY (INHALATION)
Labeler: Dispensing Solutions Inc.
Application: NDA021036
Marketing category: NDA
Marketing start: 2002-12-22
Marketing end: 0000-00-00
Substance: ZANAMIVIR
Active strength: 5 mg/1
Pharmacologic classes: Neuraminidase Inhibitor [EPC],Neuraminidase Inhibitors [MoA]
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	68258-3030		I	Inactivated by FDA		2026-08-11
excluded package	package	68258-3030	68258-3030-1	I	Inactivated by FDA		2026-08-11

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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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	68258-3030-1	`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
N021036-001	RELENZA	ZANAMIVIR	5MG	POWDER / INHALATION		RLD, RS	1999-07-26

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	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf3f65a9-7280-6c6a-2c61-3b31509b45f9	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-3030-1	2019-10-21	C162847	48780-1	956f9ecf-d1a0-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use RELENZA safely and effectively. See full prescribing information for RELENZA. RELENZA (zanamivir) Inhalation Powder, for oral inhalation Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-3030-1	RELENZA	5 in 1 CARTON	POWDER	5		1
68258-3030-1	RELENZA	4 in 1 PACKAGE	POWDER	4		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZANAMIVIR	ACTIVE INGREDIENT	L6O3XI777I	RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.]	1
ZANAMIVIR	ACTIVE MOIETY	L6O3XI777I	RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-3030	RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.]	1	Legacy NDC, 2 package rows	20100303_12ff22f6-20b5-4fa8-9028-58f87e169ff5.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
RELENZA	ZANAMIVIR	A-S Medication Solutions	b4e68930-4e6d-4d27-b1f0-abf60d12e28d	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021036 application number: NDA021036
RELENZA	ZANAMIVIR	GlaxoSmithKline LLC	d7c3bcc3-0c0d-4068-fd80-88cf54a376ef	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021036 application number: NDA021036

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L6O3XI777I	ZANAMIVIR	139110-80-8	ZANAMIVIR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
759473	RELENZA DISKHALER 5 MG/INHAL Dry Powder Inhaler, 20 Blisters	PSN	12ff22f6-20b5-4fa8-9028-58f87e169ff5	1
759471	zanamivir 5 MG/INHAL Dry Powder Inhaler, 20 Blisters	PSN	12ff22f6-20b5-4fa8-9028-58f87e169ff5	1
759473	20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler [Relenza]	SBD	12ff22f6-20b5-4fa8-9028-58f87e169ff5	1
759471	20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler	SCD	12ff22f6-20b5-4fa8-9028-58f87e169ff5	1
759473	20 ACTUAT Relenza 5 MG/ACTUAT Dry Powder Inhaler	SY	12ff22f6-20b5-4fa8-9028-58f87e169ff5	1
759473	Relenza 5 MG/ACTUAT Dry Powder Inhaler, 20 ACTUAT	SY	12ff22f6-20b5-4fa8-9028-58f87e169ff5	1
759471	zanamivir 5 MG/ACTUAT Dry Powder Inhaler, 20 ACTUAT	SY	12ff22f6-20b5-4fa8-9028-58f87e169ff5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68258-3030-1	68258303001	5 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RELENZA - Dispensing Solutions Inc.	Dispensing Solutions Inc.	2010-03-02	HUMAN PRESCRIPTION DRUG LABEL	1