Staxyn

Product NDC: 0173-0822
11-digit product format: 001730822
Labeler code: 0173
Product ID: 0173-0822_1a2c1fa7-6a5f-47e8-a487-1aa4a0e179b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vardenafil hydrochloride
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: GlaxoSmithKline LLC
Application: NDA200179
Marketing category: NDA
Marketing start: 2011-04-21
Marketing end: 0000-00-00
Substance: VARDENAFIL HYDROCHLORIDE
Active strength: 12 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0173-0822		D	Discontinued by firm	2026-08-03
excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	2026-08-03
excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	2026-08-03
excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 44 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	0173-0822		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0173-0822	0173-0822-14	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0173-0822	0173-0822-04	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0173-0822	0173-0822-61	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N200179-001	STAXYN	VARDENAFIL HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200179-001	8613950	2028-12-23		Drug product	2014-01-22

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200179-001	STAXYN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2010-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200179-001	STAXYN	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2010-06-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	N200179-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200179-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200179-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200179-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200179-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200179-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200179-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200179-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200179-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200179-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200179-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200179-001	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N200179-001	8613950	2028-12-23	Drug product	2014-01-22	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f2f15561-f1f1-39f4-fff4-873c88c535cd	Product name	4	20210224
9c8b57d3-6030-411c-8a17-97b4b8f0ea17	Product name	3	20200708
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0173-0822-04	EA - Each	0173-0822	7fa26e95-0a7e-4bff-8284-ba9c3b932b78	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VARDENAFIL HYDROCHLORIDE TRIHYDRATE	ACTIVE INGREDIENT	5M8S2CU0TS	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [GLAXOSMITHKLINE LLC]	5
VARDENAFIL	ACTIVE MOIETY	UCE6F4125H	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [GLAXOSMITHKLINE LLC]	5
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [GLAXOSMITHKLINE LLC]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [GLAXOSMITHKLINE LLC]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [GLAXOSMITHKLINE LLC]	5
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [GLAXOSMITHKLINE LLC]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [GLAXOSMITHKLINE LLC]	5
SORBITOL	INACTIVE INGREDIENT	506T60A25R	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [GLAXOSMITHKLINE LLC]	5
VARDENAFIL HYDROCHLORIDE	ACTIVE INGREDIENT	5M8S2CU0TS	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	3
VARDENAFIL	ACTIVE MOIETY	UCE6F4125H	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	3
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	STAXYN (VARDENAFIL HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [PHYSICIANS TOTAL CARE, INC.]	3

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5M8S2CU0TS	VARDENAFIL HYDROCHLORIDE	330808-88-3	VARDENAFIL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996183	Staxyn 10 MG Disintegrating Oral Tablet	PSN	1f71920c-0e54-46e8-82c8-3ea5d212d469	3
996179	vardenafil 10 MG Disintegrating Oral Tablet	PSN	1f71920c-0e54-46e8-82c8-3ea5d212d469	3
996183	vardenafil 10 MG Disintegrating Oral Tablet [Staxyn]	SBD	1f71920c-0e54-46e8-82c8-3ea5d212d469	3
996179	vardenafil 10 MG Disintegrating Oral Tablet	SCD	1f71920c-0e54-46e8-82c8-3ea5d212d469	3
996183	Staxyn 10 MG (vardenafil HCl 11.85 MG) Disintegrating Oral Tablet	SY	1f71920c-0e54-46e8-82c8-3ea5d212d469	3
996183	Staxyn 10 MG Disintegrating Oral Tablet	SY	1f71920c-0e54-46e8-82c8-3ea5d212d469	3
996179	vardenafil 10 MG (vardenafil HCl 11.85 MG) Disintegrating Oral Tablet	SY	1f71920c-0e54-46e8-82c8-3ea5d212d469	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0173-0822-04	00173082204	1 BLISTER PACK in 1 BOX (0173-0822-04) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2011-04-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Staxyn	GlaxoSmithKline LLC \| Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG	2017-08-08	HUMAN PRESCRIPTION DRUG LABEL	12
Staxyn	Physicians Total Care, Inc.	2012-04-23	HUMAN PRESCRIPTION DRUG LABEL	3