Sildenafil

Product NDC: 76420-061
11-digit product format: 764200061
Labeler code: 76420
Product ID: 76420-061_e785ec65-b5e8-693c-e053-2995a90aa9e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA203814
Marketing category: ANDA
Marketing start: 2014-01-03
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: 2026-12-31
Current FDA listing: Yes

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
A203814-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2013-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203814-001	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	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203814-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-12-17	`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	A203814-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203814-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203814-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203814-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203814-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203814-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203814-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203814-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203814-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203814-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203814-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203814-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203814-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203814-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203814-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203814-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203814-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203814-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203814-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203814-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203814-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203814-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203814-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203814-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203814-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203814-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203814-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203814-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203814-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203814-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203814-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203814-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203814-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203814-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203814-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203814-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203814-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203814-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203814-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203814-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sildenafil
Listing expiration: 2026-12-31

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
06571775-b651-4e23-a35b-88392aae7e13	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
76420-061-30	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
76420-061-60	Sildenafil	60 in 1 BOTTLE	TABLET, FILM COATED	60	2
76420-061-90	Sildenafil	90 in 1 BOTTLE	TABLET, FILM COATED	90	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-061	SILDENAFIL TABLET, FILM COATED [ASCLEMED USA, INC.]	2	Current NDC, Legacy NDC, 3 package rows	20220902_06571775-b651-4e23-a35b-88392aae7e13.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	American Health Packaging	f7fbfc3b-807e-4375-a6eb-8db0eaf40c9c	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Macleods Pharmaceuticals Limited	61a0ebd9-8dc9-4bcc-b07b-f3d6398ea96e	2025-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	BluePoint Laboratories	be6d1015-306d-44fb-8d4d-01724b8d9590	2024-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals, Inc.	46dff4c0-9a6c-20f9-e054-00144ff8d46c	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	97ccea8a-6d5a-129f-e053-2995a90aa837	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	72900ed9-dbab-3f7b-e053-2a91aa0a0d24	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	7c01fd56-5dd6-4728-9f2a-e0f5db810269	2023-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Macleods Pharmaceuticals Limited	d2892f4b-f5ba-42f5-b373-310241f4efa7	2023-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Asclemed USA, Inc.	06571775-b651-4e23-a35b-88392aae7e13	2022-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814 ndc (product): 76420-061
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	85767ed7-932b-4e2b-8bba-b59bb45ce116	2020-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814
Sildenafil	SILDENAFIL	Proficient Rx LP	2538995d-2df6-4c87-978a-5513c670b60f	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203814 application number: ANDA203814

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	06571775-b651-4e23-a35b-88392aae7e13	2
577033	sildenafil 20 MG Oral Tablet	SCD	06571775-b651-4e23-a35b-88392aae7e13	2
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	06571775-b651-4e23-a35b-88392aae7e13	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-061-30	76420006130	30 TABLET, FILM COATED in 1 BOTTLE (76420-061-30)	2019-12-10	0000-00-00	No	No	Current
76420-061-60	76420006160	60 TABLET, FILM COATED in 1 BOTTLE (76420-061-60)	2022-08-31	0000-00-00	No	No	Current
76420-061-90	76420006190	90 TABLET, FILM COATED in 1 BOTTLE (76420-061-90)	2019-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sildenafil	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2022-08-31	HUMAN PRESCRIPTION DRUG LABEL	2