Sildenafil

Product NDC: 50268-717
11-digit product format: 502680717
Labeler code: 50268
Product ID: 50268-717_436cc2bc-6fb4-227a-e063-6294a90ae221
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA202025
Marketing category: ANDA
Marketing start: 2015-05-29
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sildenafil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILDENAFIL CITRATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BW9B0ZE037	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
577033	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e08de794-9b7e-aae6-9c89-a0c0d090cc76	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-717-11	Sildenafil	1 in 1 BLISTER PACK	TABLET	1		6
50268-717-15	Sildenafil	50 in 1 BOX, UNIT-DOSE	TABLET	50		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-717-11	EA - Each	50268-717	fba4de66-2aa2-4cc6-886e-c2c6896add8b	1	2015-07-20
50268-717-15	EA - Each	50268-717	3e90a8b5-0511-4618-80f0-ad2d5b1f1f82	1	2015-07-20

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-717	SILDENAFIL TABLET [AVPAK]	5	Current NDC, Legacy NDC, 2 package rows	20240110_e08de794-9b7e-aae6-9c89-a0c0d090cc76.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 · 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 ndc (product): 50268-717
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577033	sildenafil citrate 20 MG Oral Tablet	PSN	e08de794-9b7e-aae6-9c89-a0c0d090cc76	6
577033	sildenafil 20 MG Oral Tablet	SCD	e08de794-9b7e-aae6-9c89-a0c0d090cc76	6
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	e08de794-9b7e-aae6-9c89-a0c0d090cc76	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-717-11	50268071711	1 in 1 BLISTER PACK						Historical
50268-717-15	50268071715	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-717-15) / 1 TABLET in 1 BLISTER PACK (50268-717-11)	50 blister pack	2015-05-29	0000-00-00	No	No	Current