Vardenafil Hydrochloride

Product NDC: 71610-310
Requested package NDC: 71610-310-12
11-digit product format: 716100310
Labeler code: 71610
Product ID: 71610-310_61980a1c-10b6-4f36-a192-1a82f38c1772
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vardenafil Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA209057
Marketing category: ANDA
Marketing start: 2019-01-31
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: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-310	71610-310-12	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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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
A209057-001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31
A209057-002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31
A209057-003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31
A209057-004	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209057-001	AB
A209057-002	AB
A209057-003	AB
A209057-004	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 5 · 164 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	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209057-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209057-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209057-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209057-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-10-31	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A209057-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209057-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209057-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209057-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209057-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209057-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209057-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209057-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209057-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209057-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209057-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209057-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209057-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209057-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209057-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209057-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209057-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209057-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209057-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209057-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209057-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209057-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209057-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209057-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209057-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209057-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209057-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209057-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209057-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209057-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209057-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209057-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209057-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209057-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209057-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209057-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209057-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209057-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209057-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209057-004	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, Related label table
NDC	Related label
71610-310-02	Vardenafil Hydrochloride Tablets Rx Only 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
71610-310-04	Vardenafil Hydrochloride Tablets Rx Only 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
71610-310-06	Vardenafil Hydrochloride Tablets Rx Only 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
71610-310-12	Vardenafil Hydrochloride Tablets Rx Only 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
71610-310-02	Vardenafil Hydrochloride	2 in 1 BOTTLE	TABLET	2	1
71610-310-04	Vardenafil Hydrochloride	4 in 1 BOTTLE	TABLET	4	1
71610-310-06	Vardenafil Hydrochloride	6 in 1 BOTTLE	TABLET	6	1
71610-310-12	Vardenafil Hydrochloride	12 in 1 BOTTLE	TABLET	12	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-310-02	EA - Each	71610-310	b64b691a-e7ae-4765-b6a3-1c04e3418ef1	1	2019-10-07
71610-310-04	EA - Each	71610-310	91f71986-442a-4df0-a4a2-02f2d5266c05	1	2019-10-07
71610-310-06	EA - Each	71610-310	d8b8a72c-2315-4fde-a54e-10743d6807c8	1	2019-10-07
71610-310-12	EA - Each	71610-310	d6fe0b94-32f5-46cd-ada4-124368628287	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-310	VARDENAFIL HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 4 package rows	20190817_d5470b59-59ff-455f-b602-36fc2839a941.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Lannett Company, Inc.	2782efed-6198-47b9-81ac-3e255e2ab7f6	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	AvKARE	80c4793d-e19e-10f0-e053-2991aa0a4620	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Chartwell RX, LLC	57a0c163-a5e8-4c6e-a4ea-114cb2668407	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	083a3282-254f-4042-b0eb-70f76a279f10	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	6d2859a7-6def-455f-856b-9db86b1fd355	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	666a622b-2464-4c55-8c90-0f1cc85bc1e9	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	8791997d-3b86-45af-988f-808e259da506	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	AvKARE	3b03952b-d404-09cd-e063-6294a90a8b2c	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057
Vardenafil Hydrochloride	VARDENAFIL HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	09366eb3-93e0-41d9-bf9a-24335ed3555f	2021-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209057 application number: ANDA209057

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
349480	vardenafil 20 MG Oral Tablet	PSN	d5470b59-59ff-455f-b602-36fc2839a941	1
349480	vardenafil 20 MG Oral Tablet	SCD	d5470b59-59ff-455f-b602-36fc2839a941	1
349480	vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral Tablet	SY	d5470b59-59ff-455f-b602-36fc2839a941	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-310-12	71610031012	12 TABLET in 1 BOTTLE (71610-310-12)	12 tablet	2019-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vardenafil Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2019-08-12	HUMAN PRESCRIPTION DRUG LABEL	1