Sildenafil

Product NDC: 0093-5517
11-digit product format: 000935517
Labeler code: 0093
Product ID: 0093-5517_7333aab6-b5ad-4345-b8dc-4c89676c7660
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0093-5517		D	Discontinued by firm		2026-08-17
excluded package	package	0093-5517	0093-5517-98	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
0093-5517-98	EA - Each	0093-5517	f431e114-2267-4131-9ce3-69a69161e125	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SILDENAFIL CITRATE	ACTIVE INGREDIENT	BW9B0ZE037	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7
SILDENAFIL	ACTIVE MOIETY	3M7OB98Y7H	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-5517	SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	19	Legacy NDC	20240316_2582414d-0ef3-403e-84e8-1d6c812e7eb1.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
577033	sildenafil citrate 20 MG Oral Tablet	PSN	6512178a-7358-4c2c-a341-b888f5433883	2
577033	sildenafil 20 MG Oral Tablet	SCD	6512178a-7358-4c2c-a341-b888f5433883	2
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	6512178a-7358-4c2c-a341-b888f5433883	2
577033	sildenafil citrate 20 MG Oral Tablet	PSN	72c1516f-8a0c-495c-b11f-93bdc574ad21	1
577033	sildenafil 20 MG Oral Tablet	SCD	72c1516f-8a0c-495c-b11f-93bdc574ad21	1
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	72c1516f-8a0c-495c-b11f-93bdc574ad21	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-5517-98	00093551798	90 TABLET, FILM COATED in 1 BOTTLE (0093-5517-98)	2013-05-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sildenafil	PD-Rx Pharmaceuticals, Inc.	2025-10-15	HUMAN PRESCRIPTION DRUG LABEL	20
Sildenafil	Teva Pharmaceuticals USA, Inc.	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	20
Sildenafil	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
Sildenafil	Proficient Rx LP	2020-11-01	HUMAN PRESCRIPTION DRUG LABEL	1
Sildenafil	Bryant Ranch Prepack	2020-01-19	HUMAN PRESCRIPTION DRUG LABEL	7
Sildenafil	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	8
Sildenafil	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2019-04-17	HUMAN PRESCRIPTION DRUG LABEL	1
Sildenafil	Unit Dose Services	2018-10-26	HUMAN PRESCRIPTION DRUG LABEL	2
Sildenafil	NuCare Pharmaceuticals, Inc.	2017-03-02	HUMAN PRESCRIPTION DRUG LABEL	1