VARDENAFIL HYDROCHLORIDE

Product NDC: 46708-239
Requested package NDC: 46708-239-30
11-digit product format: 467080239
Labeler code: 46708
Product ID: 46708-239_f87ba545-36e3-4d7d-aa52-3976a44e1719
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VARDENAFIL HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA214031
Marketing category: ANDA
Marketing start: 2020-08-05
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A214031-001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04
A214031-002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04
A214031-003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04
A214031-004	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214031-001	AB
A214031-002	AB
A214031-003	AB
A214031-004	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
2026-09-14 22:38:34	2026-08	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214031-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214031-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214031-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214031-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-08-04	`5bbf6a4d5a75…`

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
2026-09-14 22:38:34	2026-08	A214031-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214031-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214031-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214031-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214031-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214031-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214031-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214031-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214031-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214031-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214031-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214031-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214031-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214031-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214031-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214031-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214031-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214031-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214031-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214031-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214031-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214031-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214031-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214031-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214031-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214031-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214031-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214031-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214031-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214031-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214031-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214031-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214031-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214031-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214031-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214031-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214031-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214031-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214031-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214031-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	20 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349478	Internal RxNorm lookup
349479	Internal RxNorm lookup
349480	Internal RxNorm lookup
402273	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
9b8da728-8f52-4c1f-9f0c-4bd9736e912f	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
46708-239-30	VARDENAFIL HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30		2
46708-239-31	VARDENAFIL HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-239	VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]	2	Current NDC, Legacy NDC, 2 package rows	20230125_9b8da728-8f52-4c1f-9f0c-4bd9736e912f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Bryant Ranch Prepack	d8a5cc4b-9d9d-43af-9ee4-57381aa6368a	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214031 application number: ANDA214031
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Inc.	d2dce236-257e-44b6-93a9-9f0280257c6a	2023-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214031 application number: ANDA214031
VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Limited	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2023-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214031 application number: ANDA214031 ndc (package): 46708-239-30 ndc (product): 46708-239 ndc11 (package): 46708023930

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	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
349478	vardenafil 5 MG Oral Tablet	PSN	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
349479	vardenafil HCl 10 MG Oral Tablet	PSN	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
402273	vardenafil HCl 2.5 MG Oral Tablet	PSN	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
349479	vardenafil 10 MG Oral Tablet	SCD	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
402273	vardenafil 2.5 MG Oral Tablet	SCD	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
349480	vardenafil 20 MG Oral Tablet	SCD	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
349478	vardenafil 5 MG Oral Tablet	SCD	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
349479	vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral Tablet	SY	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
402273	vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral Tablet	SY	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
349480	vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral Tablet	SY	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2
349478	vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral Tablet	SY	9b8da728-8f52-4c1f-9f0c-4bd9736e912f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-239-30	46708023930	30 TABLET, FILM COATED in 1 BOTTLE (46708-239-30)	2020-08-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VARDENAFIL HYDROCHLORIDE	Alembic Pharmaceuticals Limited	2023-01-24	Human Prescription Drug Label	2