Sildenafil

Product NDC: 0378-1659
11-digit product format: 003781659
Labeler code: 0378
Product ID: 0378-1659_1d0e6262-2e9e-43ca-8f44-5f7e202a662c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA201171
Marketing category: ANDA
Marketing start: 2019-04-04
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 50 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0378-1659		D	Discontinued by firm		2026-10-20
excluded package	package	0378-1659	0378-1659-93	D	Discontinued by firm		2026-10-20

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 product	product	0378-1659		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-1659	0378-1659-93	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A201171-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	2019-03-25
A201171-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	2019-03-25
A201171-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	2019-03-25

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 · 132 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
2026-10-15 13:18:30	2026-09	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL		2019-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL		2019-03-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL		2019-03-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL		2019-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL		2019-03-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL		2019-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL		2019-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL		2019-03-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL		2019-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL		2019-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL		2019-03-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL		2019-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL		2019-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL		2019-03-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL		2019-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2019-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2019-03-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2019-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2019-03-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2019-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2019-03-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2019-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2019-03-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2019-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2019-03-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2019-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2019-03-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2019-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2019-03-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2019-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201171-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2019-03-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201171-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2019-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201171-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2019-03-25	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A201171-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201171-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201171-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A201171-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201171-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201171-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201171-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201171-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201171-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201171-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201171-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201171-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201171-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201171-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201171-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201171-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201171-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201171-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A201171-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201171-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201171-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A201171-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201171-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201171-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201171-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201171-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201171-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A201171-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201171-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201171-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A201171-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201171-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201171-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201171-003	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1659-93	EA - Each	0378-1659	12638b08-16c1-4952-851f-042327942779	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1659	SILDENAFIL TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	4	Legacy NDC	20250215_cad6e3ac-84e5-4dae-9c26-8f6078f0da0c.zip

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
0378-1659-93	00378165993	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1659-93)	2019-04-04	0000-00-00	No	No	Current