Sildenafil

Product NDC: 53002-1719
Requested package NDC: 53002-1719-3
11-digit product format: 530021719
Labeler code: 53002
Product ID: 53002-1719_69623a01-204b-4806-8992-5712e5aa25ba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA078380
Marketing category: ANDA
Marketing start: 2013-05-31
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1719	53002-1719-3	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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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
A078380-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL			2013-01-07

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	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL		2013-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078380-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078380-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078380-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078380-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078380-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078380-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078380-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078380-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078380-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078380-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078380-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078380-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078380-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078380-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078380-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078380-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078380-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078380-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078380-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078380-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078380-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078380-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078380-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078380-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078380-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078380-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078380-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078380-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078380-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078380-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078380-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078380-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078380-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078380-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078380-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078380-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078380-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078380-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078380-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078380-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fabccea2-36c8-9268-ee44-ec231455538f	Product name	9	20241217
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
ac996ae9-22a2-41c2-bb86-913c4aef95ad	Product name	1	20230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fc	Product name	9	20220613
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-01-30	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
2023-06-07	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
2023-01-30	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
2020-12-16	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
2020-01-31	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	Strength	SPL version
53002-1719-3	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1719	SILDENAFIL TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 1 package rows	20230609_3a334046-c27d-4480-be3f-6ce1445abcc4.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	Proficient Rx LP	72c1516f-8a0c-495c-b11f-93bdc574ad21	2020-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078380 application number: ANDA078380

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	3a334046-c27d-4480-be3f-6ce1445abcc4	5
577033	sildenafil 20 MG Oral Tablet	SCD	3a334046-c27d-4480-be3f-6ce1445abcc4	5
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	3a334046-c27d-4480-be3f-6ce1445abcc4	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1719-3	53002171903	30 TABLET, FILM COATED in 1 BOTTLE (53002-1719-3)	2018-10-01	0000-00-00	No	No	Current