VARDENAFIL

Product NDC: 71610-643
Requested package NDC: 71610-643-12
11-digit product format: 716100643
Labeler code: 71610
Product ID: 71610-643_872fc6c8-cdb2-4056-a5c8-874389bb6605
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VARDENAFIL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA208960
Marketing category: ANDA
Marketing start: 2018-10-31
Marketing end: 0000-00-00
Substance: VARDENAFIL HYDROCHLORIDE TRIHYDRATE
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	71610-643	71610-643-12	D	Discontinued by firm		2026-08-03

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	RLD / RS	Approval date
A208960-001	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31
A208960-002	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31
A208960-003	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31
A208960-004	VARDENAFIL HYDROCHLORIDE	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	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
A208960-001	AB
A208960-002	AB
A208960-003	AB
A208960-004	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.

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
2026-08-01 22:54:32	2026-06	A208960-001	VARDENAFIL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB		2018-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-002	VARDENAFIL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB		2018-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-003	VARDENAFIL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB		2018-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-004	VARDENAFIL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RS	2018-10-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A208960-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208960-004	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VARDENAFIL	VARDENAFIL	Zydus Lifesciences Limited	8ea14f7e-44a0-4d9c-968a-87b97ca12f09	2026-01-05		Exact identifier application applno (ANDA): 208960 application number: ANDA208960
VARDENAFIL	VARDENAFIL	Zydus Pharmaceuticals USA Inc.	5876e062-e604-42a7-99c3-5da30b8dac06	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208960 application number: ANDA208960
VARDENAFIL	VARDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	c70a9c8e-46b0-489d-bbda-2d7fca4b629f	2020-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208960 application number: ANDA208960

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-643-02	EA - Each	71610-643	ad8b7bcb-12fe-4eee-aee7-7857537fbce1	1	2022-06-06
71610-643-04	EA - Each	71610-643	2a7969cb-4d66-4ecf-9d32-dc99b622fc5e	1	2022-06-06
71610-643-06	EA - Each	71610-643	1c98e139-baa2-4d06-ab70-88ad4c3eb4be	1	2022-06-06
71610-643-12	EA - Each	71610-643	ae2e5a21-e6f7-403e-92f7-c8ccb40c2b8f	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-643	VARDENAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC	20220512_2dde6b40-e0be-4465-bd95-061fc9a61e22.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-643-12	71610064312	12 TABLET, FILM COATED in 1 BOTTLE (71610-643-12)	2022-04-21	0000-00-00	No	No	Current