Sildenafil

Product NDC: 50436-0776
Requested package NDC: 50436-0776-3
11-digit product format: 504360776
Labeler code: 50436
Product ID: 50436-0776_2cef835b-7f69-474e-a9b4-fae3e548df56
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA203623
Marketing category: ANDA
Marketing start: 2014-11-26
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: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50436-0776	50436-0776-3	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 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A203623-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2014-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203623-001	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	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`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	A203623-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203623-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203623-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203623-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203623-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203623-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203623-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203623-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203623-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203623-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203623-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203623-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203623-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203623-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203623-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203623-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203623-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203623-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203623-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203623-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203623-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203623-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203623-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203623-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203623-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203623-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203623-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203623-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203623-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203623-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203623-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203623-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203623-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203623-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203623-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203623-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203623-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203623-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203623-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203623-001	AB	1	`e64feba35796…`

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
50436-0776-1	These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
50436-0776-2	These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
50436-0776-3	These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
50436-0776-4	These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
50436-0776-5	These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL 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
50436-0776-1	Sildenafil	1 in 1 POUCH	TABLET, FILM COATED	1	2
50436-0776-2	Sildenafil	2 in 1 POUCH	TABLET, FILM COATED	2	2
50436-0776-3	Sildenafil	3 in 1 POUCH	TABLET, FILM COATED	3	2
50436-0776-4	Sildenafil	4 in 1 POUCH	TABLET, FILM COATED	4	2
50436-0776-5	Sildenafil	5 in 1 POUCH	TABLET, FILM COATED	5	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-0776	SILDENAFIL TABLET, FILM COATED [UNIT DOSE SERVICES]	2	Legacy NDC, 5 package rows	20220302_67459229-971e-4753-96d4-fb0e6bac94c0.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	a9f0e832-e85c-975f-e053-2995a90afa22	2025-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203623 application number: ANDA203623
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	591a4ae7-e06c-42b6-85af-f03fd2fb8959	2024-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203623 application number: ANDA203623
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	af5277be-124b-4541-b6b2-bb55246cb8ed	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203623 application number: ANDA203623
Sildenafil	SILDENAFIL	Camber Pharmaceuticals, Inc.	f9415142-a5ac-45c0-a7c2-fb1fb6751f3d	2024-04-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203623 application number: ANDA203623
Sildenafil	SILDENAFIL	A-S Medication Solutions	34845de2-9b11-49c0-b684-cc8efb31386a	2023-09-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203623 application number: ANDA203623
Sildenafil	SILDENAFIL	XLCare Pharmaceuticals, Inc.	22d70b8d-41bc-416d-89e9-e4c39db0af83	2023-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203623 application number: ANDA203623
Sildenafil	SILDENAFIL	Proficient Rx LP	55a53f64-c04a-4697-9db3-d0827fdfcc2b	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203623 application number: ANDA203623

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	67459229-971e-4753-96d4-fb0e6bac94c0	2
577033	sildenafil 20 MG Oral Tablet	SCD	67459229-971e-4753-96d4-fb0e6bac94c0	2
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	67459229-971e-4753-96d4-fb0e6bac94c0	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50436-0776-3	50436077603	3 TABLET, FILM COATED in 1 POUCH (50436-0776-3)	2022-03-01	0000-00-00	No	No	Current