Viagra

Product NDC: 63539-421
11-digit product format: 635390421
Labeler code: 63539
Product ID: 63539-421_44077f94-92ff-4cd3-ae7d-3913bd41d97a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sildenafil citrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: U.S. Pharmaceuticals
Application: NDA020895
Marketing category: NDA
Marketing start: 1998-03-27
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: 2021-12-31
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	63539-421		D	Discontinued by firm		2026-08-17
excluded package	package	63539-421	63539-421-97	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 · 24 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	63539-421-97	`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	63539-421-97	`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	63539-421-97	`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	63539-421-97	`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	63539-421-97	`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	63539-421-97	`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	63539-421-97	`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	63539-421-97	`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	63539-421-97	`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	63539-421-97	`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	63539-421-97	`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	63539-421-97	`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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SILDENAFIL CITRATE	ACTIVE INGREDIENT	BW9B0ZE037	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
SILDENAFIL	ACTIVE MOIETY	3M7OB98Y7H	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	VIAGRA (SILDENAFIL CITRATE) TABLET, FILM COATED [U.S. PHARMACEUTICALS]	5

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63539-421-97	63539042197	6 BLISTER PACK in 1 CARTON (63539-421-97) > 4 TABLET, FILM COATED in 1 BLISTER PACK	6 blister pack	1998-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Viagra	U.S. Pharmaceuticals \| Pfizer Laboratories Div Pfizer Inc \| Pfizer Ireland Pharmaceuticals \| Pfizer Pharmaceuticals LLC \| Pfizer Inc	2020-09-18	HUMAN PRESCRIPTION DRUG LABEL	8