sildenafil

Product NDC: 73160-001
11-digit product format: 731600001
Labeler code: 73160
Product ID: 73160-001_90cd56e2-b576-f061-e053-2995a90afd98
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CarePartners Pharmacy, LLC
Application: ANDA204883
Marketing category: ANDA
Marketing start: 2016-08-01
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 20 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	73160-001		D	Discontinued by firm	2026-08-11
excluded package	package	73160-001	73160-001-30	D	Discontinued by firm	2026-08-11
excluded package	package	73160-001	73160-001-60	D	Discontinued by firm	2026-08-11

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73160-001-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73160-001-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73160-001-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73160-001-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73160-001-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73160-001-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73160-001-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73160-001-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73160-001-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73160-001-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73160-001-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73160-001-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73160-001-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73160-001-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73160-001-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73160-001-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73160-001-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73160-001-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73160-001-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73160-001-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73160-001-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73160-001-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73160-001-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	73160-001-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204883-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2016-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204883-001	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 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204883-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204883-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204883-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204883-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204883-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204883-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204883-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204883-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204883-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204883-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204883-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204883-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204883-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204883-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204883-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204883-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204883-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204883-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204883-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204883-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204883-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204883-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204883-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204883-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204883-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204883-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204883-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204883-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204883-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204883-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204883-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204883-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204883-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204883-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204883-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204883-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204883-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204883-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204883-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204883-001	AB	1	`cb3db0bc1861…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil Citrate	SILDENAFIL	Northwind Health Company, LLC	471b8574-cb2a-1670-e063-6394a90a2a84	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883
Sildenafil Citrate	SILDENAFIL	Advagen Pharma Ltd	ce683bbc-a1d2-4f23-b3d1-d9333d91dc55	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883
Sildenafil Citrate	SILDENAFIL	Northwind Health Company, LLC	d9ddfd2a-1961-90f9-e053-2a95a90a7f9b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	88825206-1b91-4d95-876c-71100912d378	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883
Sildenafil Citrate	SILDENAFIL	TruPharma LLC	c8864c64-22ad-402b-a1e8-cfb53fa02e80	2020-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	9ebc1a11-3f4b-4eb3-89f5-f430a330887d	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tadalafil - CarePartners Pharmacy, LLC	CarePartners Pharmacy, LLC	2019-08-23	HUMAN PRESCRIPTION DRUG LABEL	1