Sildenafil

Product NDC: 71335-2657
Requested package NDC: 71335-2657-3
11-digit product format: 713352657
Labeler code: 71335
Product ID: 71335-2657_d6754fca-43f0-4452-aef3-0ad5c126ddfc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091479
Marketing category: ANDA
Marketing start: 2012-11-06
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091479-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2012-11-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091479-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091479-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2012-11-06	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091479-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091479-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091479-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091479-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091479-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091479-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091479-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091479-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091479-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091479-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091479-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091479-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091479-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091479-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091479-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091479-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091479-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091479-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091479-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091479-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091479-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091479-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091479-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091479-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091479-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091479-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091479-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091479-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091479-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091479-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091479-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091479-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091479-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091479-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091479-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091479-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091479-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091479-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091479-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091479-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Sildenafil
Listing expiration: 2027-12-31

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
486dcfc4-f07a-4a78-86f0-f1c5ae448dc1	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	SPL version
71335-2657-0	Sildenafil	50 in 1 BOTTLE	TABLET, FILM COATED	50	1
71335-2657-1	Sildenafil	10 in 1 BOTTLE	TABLET, FILM COATED	10	1
71335-2657-2	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
71335-2657-3	Sildenafil	7 in 1 BOTTLE	TABLET, FILM COATED	7	1
71335-2657-4	Sildenafil	90 in 1 BOTTLE	TABLET, FILM COATED	90	1
71335-2657-5	Sildenafil	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
71335-2657-6	Sildenafil	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
71335-2657-7	Sildenafil	270 in 1 BOTTLE	TABLET, FILM COATED	270	1
71335-2657-8	Sildenafil	15 in 1 BOTTLE	TABLET, FILM COATED	15	1
71335-2657-9	Sildenafil	12 in 1 BOTTLE	TABLET, FILM COATED	12	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	Cardinal Health 107, LLC	c5ac2265-393a-4fbe-b974-1dd0b9243ec8	2026-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	486dcfc4-f07a-4a78-86f0-f1c5ae448dc1	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479 ndc (package): 71335-2657-3 ndc (product): 71335-2657 ndc11 (package): 71335265703
SILDENAFIL	SILDENAFIL	Major Pharmaceuticals	a65b5fb3-ca3c-4226-9caa-42fb9a2f7373	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
Sildenafil	SILDENAFIL	Torrent Pharmaceuticals Limited	1bc081f2-399d-43fa-9e0f-9f8df0118e99	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals, Inc.	48c56418-0e45-083f-e063-6294a90a57b3	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
Sildenafil	SILDENAFIL	Proficient Rx LP	71140bd5-0a51-4c01-ad0d-193d08ea67dd	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
SILDENAFIL CITRATE	SILDENAFIL CITRATE	A-S Medication Solutions	28a3376b-e50e-4789-9916-803ba29a1522	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
Sildenafil Citrate	SILDENAFIL CITRATE	Advanced Rx Pharmacy of Tennessee, LLC	f925abbe-4977-00b0-e053-6294a90a6e53	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Asclemed USA, Inc.	49a95b25-08b3-4cfe-a60b-c5132c280be2	2023-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091479 application number: ANDA091479

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	486dcfc4-f07a-4a78-86f0-f1c5ae448dc1	1
577033	sildenafil 20 MG Oral Tablet	SCD	486dcfc4-f07a-4a78-86f0-f1c5ae448dc1	1
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	486dcfc4-f07a-4a78-86f0-f1c5ae448dc1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2657-3	71335265703	7 TABLET, FILM COATED in 1 BOTTLE (71335-2657-3)	2025-06-23	No	No	Current