Sildenafil

Product NDC: 43063-668
Requested package NDC: 43063-668-30
11-digit product format: 430630668
Labeler code: 43063
Product ID: 43063-668_efe40056-0386-6ce1-e053-2a95a90ab2e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx 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: 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	43063-668	43063-668-30	D	Discontinued by firm		2026-08-17

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-668-30	EA - Each	43063-668	a0c10c12-d5a0-408b-ac16-624ce10441c3	1	2016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-668	SILDENAFIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	19	Legacy NDC	20240606_30886aaa-4834-4a06-e054-00144ff8d46c.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-668-30	43063066830	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-668-30)	2016-04-15	0000-00-00	No	No	Current