Vardenafil

Product NDC: 46708-235
11-digit product format: 467080235
Labeler code: 46708
Product ID: 46708-235_2ca8929b-0b62-4302-9ab4-60ad3768e803
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vardenafil
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA208324
Marketing category: ANDA
Marketing start: 2018-11-20
Substance: VARDENAFIL HYDROCHLORIDE TRIHYDRATE
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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208324-001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208324-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-11-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208324-001	VARDENAFIL HYDROCHLORIDE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2018-11-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208324-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208324-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208324-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208324-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208324-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208324-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208324-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208324-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208324-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208324-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208324-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208324-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208324-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208324-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208324-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208324-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208324-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208324-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208324-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208324-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208324-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208324-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208324-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208324-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208324-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208324-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208324-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208324-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208324-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208324-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208324-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208324-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208324-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208324-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208324-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208324-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208324-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208324-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208324-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208324-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE	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
996179	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
dce0b31b-4522-4cb4-9dba-3aea2b2bb082	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
46708-235-04	Vardenafil	4 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	4		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-235	VARDENAFIL TABLET, ORALLY DISINTEGRATING [ALEMBIC PHARMACEUTICALS LIMITED]	3	Current NDC, Legacy NDC, 1 package rows	20230125_dce0b31b-4522-4cb4-9dba-3aea2b2bb082.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vardenafil	VARDENAFIL	Alembic Pharmaceuticals Inc.	0ce4eb7b-fa50-441d-ae71-eb33dca27926	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208324 application number: ANDA208324
Vardenafil	VARDENAFIL	Alembic Pharmaceuticals Limited	dce0b31b-4522-4cb4-9dba-3aea2b2bb082	2023-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208324 application number: ANDA208324 ndc (product): 46708-235

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
UCE6F4125H	VARDENAFIL	224785-90-4	Vardenafil

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996179	vardenafil 10 MG Disintegrating Oral Tablet	PSN	dce0b31b-4522-4cb4-9dba-3aea2b2bb082	3
996179	vardenafil 10 MG Disintegrating Oral Tablet	SCD	dce0b31b-4522-4cb4-9dba-3aea2b2bb082	3
996179	vardenafil 10 MG (vardenafil HCl 11.85 MG) Disintegrating Oral Tablet	SY	dce0b31b-4522-4cb4-9dba-3aea2b2bb082	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-235-04	46708023504	4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (46708-235-04)	2018-11-20	0000-00-00	No	No	Current