RELENZA

Product NDC: 0173-0681
11-digit product format: 001730681
Labeler code: 0173
Product ID: 0173-0681_244881b7-a19f-4409-abf7-2df6ad39c28e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zanamivir
Dosage form: POWDER
Route: RESPIRATORY (INHALATION)
Labeler: GlaxoSmithKline LLC
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: 2026-12-31
Current FDA listing: Yes

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…`

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
d7c3bcc3-0c0d-4068-fd80-88cf54a376ef	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0173-0681-01	RELENZA	4 in 1 PACKAGE	POWDER	4	33
0173-0681-01	RELENZA	5 in 1 CARTON	POWDER	5	33
0173-0681-22	RELENZA	4 in 1 PACKAGE	POWDER	4	33
0173-0681-22	RELENZA	5 in 1 CARTON	POWDER	5	33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0681-01	EA - Each	0173-0681	24bd1484-71df-40c8-ac59-3085c692ea6c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZANAMIVIR	ACTIVE INGREDIENT	L6O3XI777I	RELENZA (ZANAMIVIR) POWDER [GLAXOSMITHKLINE LLC]	19
ZANAMIVIR	ACTIVE MOIETY	L6O3XI777I	RELENZA (ZANAMIVIR) POWDER [GLAXOSMITHKLINE LLC]	19
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	RELENZA (ZANAMIVIR) POWDER [GLAXOSMITHKLINE LLC]	19
ZANAMIVIR	ACTIVE INGREDIENT	L6O3XI777I	RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.]	1
ZANAMIVIR	ACTIVE INGREDIENT	L6O3XI777I	RELENZA (ZANAMIVIR) POWDER [PHYSICIANS TOTAL CARE, INC.]	1
ZANAMIVIR	ACTIVE MOIETY	L6O3XI777I	RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.]	1
ZANAMIVIR	ACTIVE MOIETY	L6O3XI777I	RELENZA (ZANAMIVIR) POWDER [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	RELENZA (ZANAMIVIR) POWDER [DISPENSING SOLUTIONS INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	RELENZA (ZANAMIVIR) POWDER [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0173-0681	RELENZA (ZANAMIVIR) POWDER [GLAXOSMITHKLINE LLC]	32	Current NDC, Legacy NDC, 4 package rows	20240712_d7c3bcc3-0c0d-4068-fd80-88cf54a376ef.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 ndc (product): 0173-0681

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	d7c3bcc3-0c0d-4068-fd80-88cf54a376ef	33
759471	zanamivir 5 MG/INHAL Dry Powder Inhaler, 20 Blisters	PSN	d7c3bcc3-0c0d-4068-fd80-88cf54a376ef	33
759473	20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler [Relenza]	SBD	d7c3bcc3-0c0d-4068-fd80-88cf54a376ef	33
759471	20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler	SCD	d7c3bcc3-0c0d-4068-fd80-88cf54a376ef	33
759473	20 ACTUAT Relenza 5 MG/ACTUAT Dry Powder Inhaler	SY	d7c3bcc3-0c0d-4068-fd80-88cf54a376ef	33
759473	Relenza 5 MG/ACTUAT Dry Powder Inhaler, 20 ACTUAT	SY	d7c3bcc3-0c0d-4068-fd80-88cf54a376ef	33
759471	zanamivir 5 MG/ACTUAT Dry Powder Inhaler, 20 ACTUAT	SY	d7c3bcc3-0c0d-4068-fd80-88cf54a376ef	33
759473	RELENZA DISKHALER 5 MG/INHAL Dry Powder Inhaler, 20 Blisters	PSN	315556f2-4da0-47fc-86af-8fb61f6dd3bf	1
759471	zanamivir 5 MG/INHAL Dry Powder Inhaler, 20 Blisters	PSN	315556f2-4da0-47fc-86af-8fb61f6dd3bf	1
759473	20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler [Relenza]	SBD	315556f2-4da0-47fc-86af-8fb61f6dd3bf	1
759471	20 ACTUAT zanamivir 5 MG/ACTUAT Dry Powder Inhaler	SCD	315556f2-4da0-47fc-86af-8fb61f6dd3bf	1
759473	20 ACTUAT Relenza 5 MG/ACTUAT Dry Powder Inhaler	SY	315556f2-4da0-47fc-86af-8fb61f6dd3bf	1
759473	Relenza 5 MG/ACTUAT Dry Powder Inhaler, 20 ACTUAT	SY	315556f2-4da0-47fc-86af-8fb61f6dd3bf	1
759471	zanamivir 5 MG/ACTUAT Dry Powder Inhaler, 20 ACTUAT	SY	315556f2-4da0-47fc-86af-8fb61f6dd3bf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0173-0681-01	00173068101	5 PACKAGE in 1 CARTON (0173-0681-01) / 4 POWDER in 1 PACKAGE	5 package	1999-09-22	0000-00-00	No	No	Current
0173-0681-22	00173068122	5 PACKAGE in 1 CARTON (0173-0681-22) / 4 POWDER in 1 PACKAGE	5 package	2007-03-09		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
RELENZA - GlaxoSmithKline LLC	GlaxoSmithKline LLC	2023-10-24	HUMAN PRESCRIPTION DRUG LABEL	34
RELENZA - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-03-02	HUMAN PRESCRIPTION DRUG LABEL	1