Sildenafil

Product NDC: 71335-1649
Requested package NDC: 71335-1649-1
11-digit product format: 713351649
Labeler code: 71335
Product ID: 71335-1649_841b6c33-e16d-4bbb-80df-3c35c73287d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA203623
Marketing category: ANDA
Marketing start: 2014-11-26
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 1.

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 · 41 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
2026-02-19 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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203623-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2014-11-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203623-001	AB	1	`cb3db0bc1861…`

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
af5277be-124b-4541-b6b2-bb55246cb8ed	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
71335-1649-0	Sildenafil	50 in 1 BOTTLE	TABLET, FILM COATED	50	8
71335-1649-1	Sildenafil	10 in 1 BOTTLE	TABLET, FILM COATED	10	8
71335-1649-2	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
71335-1649-3	Sildenafil	7 in 1 BOTTLE	TABLET, FILM COATED	7	8
71335-1649-4	Sildenafil	90 in 1 BOTTLE	TABLET, FILM COATED	90	8
71335-1649-5	Sildenafil	60 in 1 BOTTLE	TABLET, FILM COATED	60	8
71335-1649-6	Sildenafil	20 in 1 BOTTLE	TABLET, FILM COATED	20	8
71335-1649-7	Sildenafil	270 in 1 BOTTLE	TABLET, FILM COATED	270	8
71335-1649-8	Sildenafil	15 in 1 BOTTLE	TABLET, FILM COATED	15	8
71335-1649-9	Sildenafil	12 in 1 BOTTLE	TABLET, FILM COATED	12	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1649-2	EA - Each	71335-1649	c87f69fc-d3ca-4989-aebf-41a8923e2d5c	1	2023-05-05
71335-1649-4	EA - Each	71335-1649	441ce3cb-087d-4843-819c-60eb66d14645	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1649	SILDENAFIL (SILDENAFIL) TABLET, FILM COATED [BRYANT RANCH PREPACK]	8	Current NDC, Legacy NDC, 10 package rows	20240823_af5277be-124b-4541-b6b2-bb55246cb8ed.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 ndc (package): 71335-1649-1 ndc (product): 71335-1649 ndc11 (package): 71335164901
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	af5277be-124b-4541-b6b2-bb55246cb8ed	8
577033	sildenafil 20 MG Oral Tablet	SCD	af5277be-124b-4541-b6b2-bb55246cb8ed	8
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	af5277be-124b-4541-b6b2-bb55246cb8ed	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1649-1	71335164901	10 TABLET, FILM COATED in 1 BOTTLE (71335-1649-1)	2020-07-09	0000-00-00	No	No	Current