Sildenafil

Product NDC: 42291-748
Requested package NDC: 42291-748-06
11-digit product format: 422910748
Labeler code: 42291
Product ID: 42291-748_e80922f4-a465-b8c4-e053-2a95a90af313
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AvKARE
Application: ANDA077342
Marketing category: ANDA
Marketing start: 2018-05-29
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 100 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#

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	42291-748	42291-748-06	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
42291-748-01	EA - Each	42291-748	1544d3e4-0b53-4315-9c33-a23c89bb9042	1	2018-10-11
42291-748-02	EA - Each	42291-748	63373803-92bb-442d-b45c-bb2ee9b3a83c	1	2018-10-11
42291-748-04	EA - Each	42291-748	f38b0601-3987-4368-a40c-3206fa155269	1	2018-10-11
42291-748-06	EA - Each	42291-748	e7dac2f4-3241-4127-8114-142fe147e722	1	2018-10-11
42291-748-12	EA - Each	42291-748	a518c19a-ee06-48e8-bc2a-b4393adcfb8c	1	2018-10-11
42291-748-18	EA - Each	42291-748	9771e827-0237-4ff7-af02-88819af5a0e8	1	2019-02-13
42291-748-30	EA - Each	42291-748	acfde6a5-3001-43be-bc43-1bfaaa6e6b6e	1	2018-10-11

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
42291-748-06	42291074806	6 TABLET, FILM COATED in 1 BOTTLE (42291-748-06)	2018-05-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sildenafil	AvKARE	2024-04-04	HUMAN PRESCRIPTION DRUG LABEL	9
Sildenafil	Aphena Pharma Solutions - Tennessee, LLC	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	5