Sildenafil

Product NDC: 71610-271
Requested package NDC: 71610-271-02
11-digit product format: 716100271
Labeler code: 71610
Product ID: 71610-271_35c2453d-fbb5-4101-9e04-bd47131d3ada
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA077342
Marketing category: ANDA
Marketing start: 2018-05-29
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 25 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	71610-271	71610-271-02	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-271	71610-271-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-271	71610-271-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A077342-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09
A077342-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09
A077342-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A077342-001	AB
A077342-002	AB
A077342-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A077342-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077342-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077342-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077342-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077342-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-271-02	EA - Each	71610-271	6f3771bf-3cde-4c2a-b770-07c81049fbe1	1	2019-06-19
71610-271-04	EA - Each	71610-271	024e65d4-55a1-4d24-aae7-1afe42fbeead	1	2019-06-19
71610-271-06	EA - Each	71610-271	c85ba3e7-0fc2-4244-b1cf-8828ca93879d	1	2019-06-19
71610-271-12	EA - Each	71610-271	92b4f24a-647f-4c22-a5c7-1dd456b0313f	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-271	SILDENAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20190515_7fa82ca0-3e75-4424-918b-520678975ca5.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	f9ab796c-1912-4137-abec-e8336a850a58	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342
Sildenafil	SILDENAFIL	Teva Pharmaceuticals USA, Inc.	5cbac450-f336-45bd-8d10-9ecfd21866eb	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342
Sildenafil	SILDENAFIL	Proficient Rx LP	43a036a4-8a34-4411-ac8e-bf5063d67d48	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342
Sildenafil	SILDENAFIL	Proficient Rx LP	94eb1f59-2a7d-4230-9ae6-69c34d083326	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BW9B0ZE037	SILDENAFIL CITRATE	171599-83-0	SILDENAFIL CITRATE
3M7OB98Y7H	SILDENAFIL	139755-83-2	Sildenafil

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-271-02	71610027102	2 TABLET, FILM COATED in 1 BOTTLE (71610-271-02)	2019-05-01	0000-00-00	No	No	Current