RELENZA

Product NDC: 50090-8016
11-digit product format: 500908016
Labeler code: 50090
Product ID: 50090-8016_571ce280-f506-436c-b378-d570cceae236
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zanamivir
Dosage form: POWDER
Route: RESPIRATORY (INHALATION)
Labeler: A-S Medication Solutions
Application: NDA021036
Marketing category: NDA
Marketing start: 1999-09-22
Substance: ZANAMIVIR
Active strength: 5 mg/1
Pharmacologic classes: Neuraminidase Inhibitor [EPC], Neuraminidase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021036-001	RELENZA	5MG	POWDER / INHALATION	RLD, RS	1999-07-26	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: RELENZA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZANAMIVIR	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L6O3XI777I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
759471	Internal RxNorm lookup
759473	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b4e68930-4e6d-4d27-b1f0-abf60d12e28d	Available on FDA.report

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 ndc (product): 50090-8016
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8016-0	50090801600	5 PACKAGE in 1 CARTON (50090-8016-0) / 4 POWDER in 1 PACKAGE	5 package	2026-07-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RELENZA - A-S Medication Solutions	A-S Medication Solutions	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	2