Levitra

Product NDC: 67544-507
11-digit product format: 675440507
Labeler code: 67544
Product ID: 67544-507_2f463f71-cfb1-4db3-a004-02b88ceae1ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vardenafil hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: APHENA PHARMA SOLUTIONS - TENNESSEE, INC.
Application: NDA021400
Marketing category: NDA
Marketing start: 2008-05-15
Marketing end: 0000-00-00
Substance: VARDENAFIL HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67544-507		I	Inactivated by FDA	2026-08-11
excluded package	package	67544-507	67544-507-02	I	Inactivated by FDA	2026-08-11
excluded package	package	67544-507	67544-507-03	I	Inactivated by FDA	2026-08-11
excluded package	package	67544-507	67544-507-04	I	Inactivated by FDA	2026-08-11
excluded package	package	67544-507	67544-507-06	I	Inactivated by FDA	2026-08-11
excluded package	package	67544-507	67544-507-12	I	Inactivated by FDA	2026-08-11
excluded package	package	67544-507	67544-507-52	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 3 · 154 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	67544-507-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-507-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-507-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-507-52	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-507-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67544-507-12	`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	67544-507-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-507-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-507-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-507-52	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-507-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67544-507-12	`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	67544-507-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-507-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-507-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-507-52	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-507-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67544-507-12	`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	67544-507-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-507-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-507-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-507-52	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-507-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67544-507-12	`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	67544-507-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-507-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-507-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-507-52	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-507-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67544-507-12	`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	67544-507-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-507-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-507-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-507-52	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-507-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67544-507-12	`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	67544-507-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-507-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-507-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-507-52	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-507-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67544-507-12	`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	67544-507-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-507-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-507-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-507-52	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-507-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67544-507-12	`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	67544-507-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-507-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67544-507-06	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021400-001	LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19
N021400-002	LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19
N021400-003	LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19
N021400-004	LEVITRA	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N021400-001	8273876	2027-07-23	U-1288	2012-10-24
N021400-002	8273876	2027-07-23	U-1288
N021400-003	8273876	2027-07-23	U-1288
N021400-004	8273876	2027-07-23	U-1288

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 5 · 164 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	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021400-001	LEVITRA	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021400-002	LEVITRA	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021400-003	LEVITRA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021400-004	LEVITRA	EQ 20MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2003-08-19	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021400-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021400-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021400-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021400-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021400-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021400-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021400-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021400-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021400-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021400-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021400-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021400-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021400-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021400-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021400-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021400-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021400-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021400-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021400-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021400-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021400-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021400-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021400-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021400-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021400-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021400-004	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 260 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021400-002	8273876	2027-07-23	U-1288		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021400-003	8273876	2027-07-23	U-1288		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021400-004	8273876	2027-07-23	U-1288		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-002	8273876	2027-07-23	U-1288		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-003	8273876	2027-07-23	U-1288		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021400-004	8273876	2027-07-23	U-1288		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021400-002	8273876	2027-07-23	U-1288		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021400-003	8273876	2027-07-23	U-1288		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021400-004	8273876	2027-07-23	U-1288		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-002	8273876	2027-07-23	U-1288		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-003	8273876	2027-07-23	U-1288		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021400-004	8273876	2027-07-23	U-1288		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-002	8273876	2027-07-23	U-1288		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-003	8273876	2027-07-23	U-1288		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021400-004	8273876	2027-07-23	U-1288		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-002	8273876	2027-07-23	U-1288		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-003	8273876	2027-07-23	U-1288		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021400-004	8273876	2027-07-23	U-1288		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-002	8273876	2027-07-23	U-1288		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-003	8273876	2027-07-23	U-1288		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021400-004	8273876	2027-07-23	U-1288		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-002	8273876	2027-07-23	U-1288		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-003	8273876	2027-07-23	U-1288		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021400-004	8273876	2027-07-23	U-1288		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021400-002	8273876	2027-07-23	U-1288		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021400-003	8273876	2027-07-23	U-1288		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021400-004	8273876	2027-07-23	U-1288		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021400-001	8273876	2027-07-23	U-1288	2012-10-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021400-002	8273876	2027-07-23	U-1288		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021400-003	8273876	2027-07-23	U-1288		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021400-004	8273876	2027-07-23	U-1288		`d06236e962d9…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f2f15561-f1f1-39f4-fff4-873c88c535cd	Product name	4	20210224
9c8b57d3-6030-411c-8a17-97b4b8f0ea17	Product name	3	20200708

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67544-507-02	Vardenafil HCl (Levitra ® ) 10mg and 20mg Tablets Rx Only
67544-507-03	Vardenafil HCl (Levitra ® ) 10mg and 20mg Tablets Rx Only
67544-507-04	Vardenafil HCl (Levitra ® ) 10mg and 20mg Tablets Rx Only
67544-507-06	Vardenafil HCl (Levitra ® ) 10mg and 20mg Tablets Rx Only
67544-507-12	Vardenafil HCl (Levitra ® ) 10mg and 20mg Tablets Rx Only
67544-507-52	Vardenafil HCl (Levitra ® ) 10mg and 20mg Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67544-507-02	Levitra	2 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	2	1
67544-507-03	Levitra	3 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	3	1
67544-507-04	Levitra	4 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	4	1
67544-507-06	Levitra	6 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	6	1
67544-507-12	Levitra	12 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	12	1
67544-507-52	Levitra	18 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	18	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-507-02	EA - Each	67544-507	c7395525-d0f6-4ca6-8d62-ad1a39933699	1	2012-07-24
67544-507-03	EA - Each	67544-507	367dd60a-0173-4050-8a43-a4203043833e	1	2012-07-24
67544-507-04	EA - Each	67544-507	01fc580e-4c35-4d13-a081-44dab39c4e93	1	2012-07-24
67544-507-06	EA - Each	67544-507	a550a421-4437-45a1-8046-dcd395f897cd	1	2012-07-24
67544-507-12	EA - Each	67544-507	7790c155-ab02-48bc-a301-17eac1b85993	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VARDENAFIL HYDROCHLORIDE	ACTIVE INGREDIENT	5M8S2CU0TS	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
VARDENAFIL	ACTIVE MOIETY	UCE6F4125H	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-507	LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]	1	Legacy NDC, 6 package rows	20111027_34c30372-08b0-4060-8aba-779b5bc1e5dd.zip

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
404638	LEVITRA 10 MG Oral Tablet	PSN	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
404639	LEVITRA 20 MG Oral Tablet	PSN	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
349480	vardenafil 20 MG Oral Tablet	PSN	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
349479	vardenafil HCl 10 MG Oral Tablet	PSN	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
404638	vardenafil 10 MG Oral Tablet [Levitra]	SBD	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
404639	vardenafil 20 MG Oral Tablet [Levitra]	SBD	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
349479	vardenafil 10 MG Oral Tablet	SCD	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
349480	vardenafil 20 MG Oral Tablet	SCD	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
404639	Levitra (as vardenafil HCl) 20 MG Oral Tablet	SY	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
404638	Levitra (as vardenafil hydrochloride) 10 MG Oral Tablet	SY	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
404638	Levitra 10 MG Oral Tablet	SY	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
404639	Levitra 20 MG Oral Tablet	SY	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
349479	vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral Tablet	SY	34c30372-08b0-4060-8aba-779b5bc1e5dd	1
349480	vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral Tablet	SY	34c30372-08b0-4060-8aba-779b5bc1e5dd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
67544-507-02	67544050702	2 in 1 BOTTLE, PLASTIC	Historical
67544-507-03	67544050703	3 in 1 BOTTLE, PLASTIC	Historical
67544-507-04	67544050704	4 in 1 BOTTLE, PLASTIC	Historical
67544-507-06	67544050706	6 in 1 BOTTLE, PLASTIC	Historical
67544-507-12	67544050712	12 in 1 BOTTLE, PLASTIC	Historical
67544-507-52	67544050752	18 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vardenafil HCl (Levitra ® ) 10mg and 20mg Tablets Rx Only	APHENA PHARMA SOLUTIONS - TENNESSEE, INC. \| Bayer HealthCare Pharmaceuticals Inc. \| Bayer Schering Pharma AG	2011-10-26	HUMAN PRESCRIPTION DRUG LABEL	1