Vardenafil Hydrochloride

Product NDC: 73750-105
11-digit product format: 737500105
Labeler code: 73750
Product ID: 73750-105_db8e52bb-02ac-9e93-e053-2a95a90a7c85
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vardenafil Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: QYK BRANDS LLC
Application: ANDA204632
Marketing category: ANDA
Marketing start: 2022-03-01
Marketing end: 0000-00-00
Substance: VARDENAFIL
Active strength: 20 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	73750-105		I	Inactivated by FDA	2026-08-03
excluded package	package	73750-105	73750-105-10	I	Inactivated by FDA	2026-08-03
excluded package	package	73750-105	73750-105-11	I	Inactivated by FDA	2026-08-03
excluded package	package	73750-105	73750-105-30	I	Inactivated by FDA	2026-08-03

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 · 60 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	73750-105-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73750-105-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73750-105-10	`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	73750-105-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73750-105-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73750-105-10	`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	73750-105-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73750-105-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73750-105-10	`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	73750-105-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73750-105-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73750-105-10	`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	73750-105-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73750-105-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73750-105-10	`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	73750-105-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73750-105-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73750-105-10	`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	73750-105-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73750-105-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73750-105-10	`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	73750-105-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73750-105-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73750-105-10	`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	73750-105-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73750-105-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73750-105-10	`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	73750-105-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73750-105-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73750-105-10	`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	73750-105-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73750-105-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73750-105-10	`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	73750-105-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73750-105-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73750-105-10	`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	73750-105-11	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73750-105-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	73750-105-10	`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	73750-105-11	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73750-105-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	73750-105-10	`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	73750-105-11	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73750-105-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	73750-105-10	`1332a3947898…`	`d4bfe170f9cd…`

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	TE codes	Approval date
A204632-001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22
A204632-002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22
A204632-003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22
A204632-004	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A204632-001	AB
A204632-002	AB
A204632-003	AB
A204632-004	AB

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 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204632-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2019-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2019-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2019-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2019-10-22	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204632-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204632-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204632-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204632-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204632-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204632-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204632-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204632-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204632-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204632-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204632-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204632-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204632-004	AB	1	`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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73750-105-10	2023-07-28	C162847	48780-1	0191ceaa-65ee-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets. VARDENAFIL HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003
73750-105-11	2023-07-28	C162847	48780-1	0191ceaa-65ee-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets. VARDENAFIL HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003
73750-105-30	2023-07-28	C162847	48780-1	0191ceaa-65ee-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets. VARDENAFIL HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73750-105-10	Vardenafil Hydrochloride	100 in 1 BOTTLE	TABLET	100	2
73750-105-11	Vardenafil Hydrochloride	10 in 1 BLISTER PACK	TABLET	10	2
73750-105-11	Vardenafil Hydrochloride	5 in 1 CARTON	TABLET	5	2
73750-105-30	Vardenafil Hydrochloride	30 in 1 BOTTLE	TABLET	30	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73750-105	VARDENAFIL HYDROCHLORIDE TABLET [QYK BRANDS LLC]	2	Legacy NDC, 4 package rows	20220402_db63310a-37f3-202b-e053-2995a90a5520.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Macleods Pharmaceuticals Limited	a38de6e1-21ca-4ebe-a3c7-6f849cf8b675	2023-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204632 application number: ANDA204632

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UCE6F4125H	VARDENAFIL	224785-90-4	VARDENAFIL
5M8S2CU0TS	VARDENAFIL HYDROCHLORIDE	330808-88-3	Vardenafil Hydrochloride

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349480	vardenafil 20 MG Oral Tablet	PSN	db63310a-37f3-202b-e053-2995a90a5520	2
349478	vardenafil 5 MG Oral Tablet	PSN	db63310a-37f3-202b-e053-2995a90a5520	2
349479	vardenafil HCl 10 MG Oral Tablet	PSN	db63310a-37f3-202b-e053-2995a90a5520	2
402273	vardenafil HCl 2.5 MG Oral Tablet	PSN	db63310a-37f3-202b-e053-2995a90a5520	2
349479	vardenafil 10 MG Oral Tablet	SCD	db63310a-37f3-202b-e053-2995a90a5520	2
402273	vardenafil 2.5 MG Oral Tablet	SCD	db63310a-37f3-202b-e053-2995a90a5520	2
349480	vardenafil 20 MG Oral Tablet	SCD	db63310a-37f3-202b-e053-2995a90a5520	2
349478	vardenafil 5 MG Oral Tablet	SCD	db63310a-37f3-202b-e053-2995a90a5520	2
349479	vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral Tablet	SY	db63310a-37f3-202b-e053-2995a90a5520	2
402273	vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral Tablet	SY	db63310a-37f3-202b-e053-2995a90a5520	2
349480	vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral Tablet	SY	db63310a-37f3-202b-e053-2995a90a5520	2
349478	vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral Tablet	SY	db63310a-37f3-202b-e053-2995a90a5520	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73750-105-10	73750010510	100 TABLET in 1 BOTTLE (73750-105-10)	100 tablet	2022-03-01	0000-00-00	No	No	Current
73750-105-11	73750010511	5 BLISTER PACK in 1 CARTON (73750-105-11) > 10 TABLET in 1 BLISTER PACK	5 blister pack	2022-03-01	0000-00-00	No	No	Current
73750-105-30	73750010530	30 TABLET in 1 BOTTLE (73750-105-30)	30 tablet	2022-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vardenafil Hydrochloride	QYK BRANDS LLC \| Macleods Pharmaceuticals Limited	2022-03-31	HUMAN PRESCRIPTION DRUG LABEL	2