Vardenafil Hydrochloride

Product NDC: 71335-9696
11-digit product format: 713359696
Labeler code: 71335
Product ID: 71335-9696_c4b53c3e-e0c7-4368-beda-8c27a32ad5c9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vardenafil Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209057
Marketing category: ANDA
Marketing start: 2018-11-01
Substance: VARDENAFIL HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 71335-9696
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

Additional Listing Data#

Finished product: Yes
Brand name base: Vardenafil Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VARDENAFIL HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5M8S2CU0TS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349479	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8791997d-3b86-45af-988f-808e259da506	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-9696-1	Vardenafil Hydrochloride	30 in 1 BOTTLE	TABLET	30		103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-9696	VARDENAFIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	102	Current NDC, 1 package rows	20240918_8791997d-3b86-45af-988f-808e259da506.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
349479	vardenafil HCl 10 MG Oral Tablet	PSN	8791997d-3b86-45af-988f-808e259da506	103
349479	vardenafil 10 MG Oral Tablet	SCD	8791997d-3b86-45af-988f-808e259da506	103
349479	vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral Tablet	SY	8791997d-3b86-45af-988f-808e259da506	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-9696-1	71335969601	30 TABLET in 1 BOTTLE (71335-9696-1)	30 tablet	2023-04-12	No	No	Current