Viagra

Product NDC: 43353-764
11-digit product format: 433530764
Labeler code: 43353
Product ID: 43353-764_ba60c834-54c3-4aa7-bb56-8bd769b7b39e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sildenafil citrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA020895
Marketing category: NDA
Marketing start: 1998-03-27
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-764		I	Inactivated by FDA	2026-08-17
excluded package	package	43353-764	43353-764-02	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-764	43353-764-04	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-764	43353-764-06	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-764	43353-764-12	I	Inactivated by FDA	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 2 · 75 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	43353-764-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-764-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-764-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-764-02	`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	43353-764-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-764-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-764-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-764-02	`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	43353-764-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-764-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-764-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-764-02	`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	43353-764-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-764-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-764-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-764-02	`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	43353-764-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-764-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-764-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-764-02	`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	43353-764-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-764-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-764-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-764-02	`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	43353-764-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-764-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-764-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-764-02	`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	43353-764-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-764-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-764-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-764-02	`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	43353-764-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-764-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-764-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-764-02	`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	43353-764-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-764-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-764-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-764-02	`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	43353-764-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-764-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-764-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-764-02	`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	43353-764-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-764-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-764-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-764-02	`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	RLD / RS	Approval date
N020895-001	VIAGRA	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27
N020895-002	VIAGRA	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27
N020895-003	VIAGRA	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020895-001	AB
N020895-002	AB
N020895-003	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-002	VIAGRA	EQ 50MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-003	VIAGRA	EQ 100MG BASE	TABLET / ORAL	AB	RLD, RS	1998-03-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020895-001	VIAGRA	EQ 25MG BASE	TABLET / ORAL	AB	RLD	1998-03-27	`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	N020895-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020895-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020895-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020895-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020895-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020895-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020895-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020895-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020895-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020895-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020895-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020895-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020895-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020895-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020895-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020895-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020895-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020895-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020895-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020895-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020895-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020895-001	AB	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020895-001	6469012	2019-10-22	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020895-002	6469012	2019-10-22	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020895-003	6469012	2019-10-22	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020895-001	6469012	2019-10-22	U-155		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020895-002	6469012	2019-10-22	U-155		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020895-003	6469012	2019-10-22	U-155		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020895-001	6469012	2019-10-22	U-155		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020895-002	6469012	2019-10-22	U-155		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020895-003	6469012	2019-10-22	U-155		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020895-001	6469012	2019-10-22	U-155		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020895-001	6469012*PED	2020-04-22		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020895-002	6469012	2019-10-22	U-155		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020895-002	6469012*PED	2020-04-22		Pediatric extension	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020895-003	6469012	2019-10-22	U-155		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020895-003	6469012*PED	2020-04-22		Pediatric extension	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fabccea2-36c8-9268-ee44-ec231455538f	Product name	9	20241217
ac996ae9-22a2-41c2-bb86-913c4aef95ad	Product name	1	20230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fc	Product name	9	20220613

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-764-02	These highlights do not include all the information needed to use VIAGRA safely and effectively. See full prescribing information for VIAGRA. VIAGRA® (sildenafil citrate) tablets, for oral use Initial U.S. Approval: 1998
43353-764-04	These highlights do not include all the information needed to use VIAGRA safely and effectively. See full prescribing information for VIAGRA. VIAGRA® (sildenafil citrate) tablets, for oral use Initial U.S. Approval: 1998
43353-764-06	These highlights do not include all the information needed to use VIAGRA safely and effectively. See full prescribing information for VIAGRA. VIAGRA® (sildenafil citrate) tablets, for oral use Initial U.S. Approval: 1998
43353-764-12	These highlights do not include all the information needed to use VIAGRA safely and effectively. See full prescribing information for VIAGRA. VIAGRA® (sildenafil citrate) tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-764-02	Viagra	2 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	2	3
43353-764-04	Viagra	4 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	4	3
43353-764-06	Viagra	6 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	6	3
43353-764-12	Viagra	12 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	12	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-764-02	EA - Each	43353-764	aa294687-81ae-47fc-8e9c-78da7c636bb1	1	2014-05-02
43353-764-04	EA - Each	43353-764	c1e629f3-c2a9-4360-8518-63a29bc5ec8d	1	2020-01-03
43353-764-06	EA - Each	43353-764	565b35a2-8118-4e07-86a2-146102c98e55	1	2014-05-02
43353-764-12	EA - Each	43353-764	5bf53b64-c551-4ac2-b355-4e1c172d6b09	1	2020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SILDENAFIL CITRATE	ACTIVE INGREDIENT	BW9B0ZE037	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILDENAFIL	ACTIVE MOIETY	3M7OB98Y7H	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-764	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 4 package rows	20191220_47af30e9-a189-4721-8c8f-652256df75a1.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil Citrate	SILDENAFIL CITRATE	Mylan Pharmaceuticals Inc.	98a9897b-0cbc-4ea6-9ac2-4dd719a2ede0	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020895 application number: NDA020895
Viagra	SILDENAFIL CITRATE	Viatris Specialty LLC	d905dc8d-917f-4ea3-a4ee-a1ecf6967d4e	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020895 application number: NDA020895
Viagra	SILDENAFIL CITRATE	PFIZER LABORATORIES DIV PFIZER INC	0b0be196-0c62-461c-94f4-9a35339b4501	2017-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020895 application number: NDA020895

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314228	sildenafil citrate 25 MG Oral Tablet	PSN	47af30e9-a189-4721-8c8f-652256df75a1	3
213269	Viagra 25 MG Oral Tablet	PSN	47af30e9-a189-4721-8c8f-652256df75a1	3
213269	sildenafil 25 MG Oral Tablet [Viagra]	SBD	47af30e9-a189-4721-8c8f-652256df75a1	3
314228	sildenafil 25 MG Oral Tablet	SCD	47af30e9-a189-4721-8c8f-652256df75a1	3
314228	sildenafil 25 MG (as sildenafil citrate) Oral Tablet	SY	47af30e9-a189-4721-8c8f-652256df75a1	3
213269	Viagra 25 MG (as sildenafil citrate) Oral Tablet	SY	47af30e9-a189-4721-8c8f-652256df75a1	3
213269	Viagra 25 MG Oral Tablet	SY	47af30e9-a189-4721-8c8f-652256df75a1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-764-02	43353076402	2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-764-02)	2011-11-20	0000-00-00	No	No	Current
43353-764-04	43353076404	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-764-04)	2015-03-13	0000-00-00	No	No	Current
43353-764-06	43353076406	6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-764-06)	2011-11-19	0000-00-00	No	No	Current
43353-764-12	43353076412	12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-764-12)	2015-03-15	0000-00-00	No	No	Current