Sildenafil

Product NDC: 68001-176
11-digit product format: 680010176
Labeler code: 68001
Product ID: 68001-176_9b3b81dd-627d-4407-98e0-5c2b9b1d54d7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA202025
Marketing category: ANDA
Marketing start: 2013-02-28
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68001-176		D	Discontinued by firm		2026-08-17
excluded package	package	68001-176	68001-176-05	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	68001-176-05	`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	68001-176-05	`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	68001-176-05	`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	68001-176-05	`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	68001-176-05	`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	68001-176-05	`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	68001-176-05	`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	68001-176-05	`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	68001-176-05	`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	68001-176-05	`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	68001-176-05	`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	68001-176-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202025-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2013-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202025-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202025-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-02-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A202025-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202025-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202025-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202025-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202025-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202025-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202025-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202025-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202025-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202025-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202025-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202025-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202025-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202025-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202025-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202025-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202025-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202025-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202025-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202025-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202025-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202025-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202025-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202025-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202025-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202025-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202025-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202025-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202025-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202025-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202025-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202025-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202025-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202025-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202025-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202025-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202025-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202025-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202025-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202025-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-176-05	EA - Each	68001-176	16af3b2c-d873-47e9-a079-1f5dc4ce6fc1	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SILDENAFIL CITRATE	ACTIVE INGREDIENT	BW9B0ZE037	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
SILDENAFIL	ACTIVE MOIETY	3M7OB98Y7H	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SILDENAFIL TABLET [BLUEPOINT LABORATORIES]	3
SILDENAFIL CITRATE	ACTIVE INGREDIENT	BW9B0ZE037	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1
SILDENAFIL	ACTIVE MOIETY	3M7OB98Y7H	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SILDENAFIL TABLET [AMERICAN HEALTH PACKAGING]	1

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	A-S Medication Solutions	dc38f412-dca7-4b54-b14c-314e7a251ee6	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	a636d3c7-af25-4148-8b4e-6f44deba700b	2026-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	Amneal Pharmaceuticals LLC	187de471-3e79-44ed-b560-0f8b2d549f74	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	REMEDYREPACK INC.	f5113b5e-9087-4397-86bc-5ea10413c429	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	AvKARE	21c83ff3-c359-3269-e063-6394a90a57ee	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	Northwind Health Company, LLC	fa14cb6b-0fa8-0ba0-e053-6294a90afae3	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	AvPAK	e08de794-9b7e-aae6-9c89-a0c0d090cc76	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	Amneal Pharmaceuticals of New York LLC	a0b734f4-9347-484d-b307-d493ae50ee54	2024-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025
Sildenafil	SILDENAFIL	Proficient Rx LP	38a5592a-c14a-40af-a19a-588cb11090ed	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202025 application number: ANDA202025

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-176-05	68001017605	90 TABLET in 1 BOTTLE (68001-176-05)	90 tablet	2013-02-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sildenafil	American Health Packaging	2019-03-04	HUMAN PRESCRIPTION DRUG LABEL	4
Sildenafil	BluePoint Laboratories \| Amneal Pharmaceuticals \| Amneal Pharmaceuticals Pvt. Ltd.	2018-02-28	HUMAN PRESCRIPTION DRUG LABEL	9