Sildenafil

Product NDC: 27808-163
11-digit product format: 278080163
Labeler code: 27808
Product ID: 27808-163_d737452f-646c-7bfe-e053-2a95a90a61c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sildenafil citrate
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Tris Pharma Inc
Application: ANDA212312
Marketing category: ANDA
Marketing start: 2021-11-17
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 10 mg/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	27808-163		D	Discontinued by firm		2026-08-03
excluded package	package	27808-163	27808-163-01	D	Discontinued by firm		2026-08-03

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	27808-163-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	27808-163-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	27808-163-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	27808-163-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	27808-163-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	27808-163-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	27808-163-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	27808-163-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	27808-163-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A212312-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL			2021-11-17

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL	AB	2021-11-17	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212312-001	SILDENAFIL CITRATE	EQ 10MG BASE/ML	FOR SUSPENSION / ORAL		2021-11-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A212312-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212312-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212312-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212312-001	AB	1	`782e0a99824c…`

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BW9B0ZE037	SILDENAFIL CITRATE	171599-83-0	SILDENAFIL CITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27808-163-01	27808016301	1 BOTTLE in 1 CARTON (27808-163-01) > 112 mL in 1 BOTTLE	1 bottle	2022-11-17	0000-00-00	No	No	Current