Sildenafil

Product NDC: 71335-1963
11-digit product format: 713351963
Labeler code: 71335
Product ID: 71335-1963_8cf40711-534a-4663-9a3b-d92dcc1fe0e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA210394
Marketing category: ANDA
Marketing start: 2018-05-04
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
A210394-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2018-05-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210394-001	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	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`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	A210394-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210394-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210394-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210394-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210394-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210394-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210394-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210394-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210394-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210394-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210394-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210394-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210394-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210394-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210394-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210394-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210394-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210394-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210394-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210394-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210394-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210394-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210394-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210394-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210394-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210394-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210394-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210394-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210394-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210394-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210394-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210394-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210394-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210394-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210394-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210394-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210394-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210394-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210394-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210394-001	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
fe848310-57d8-4492-829c-3e2535754a55	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
71335-1963-0	Sildenafil	50 in 1 BOTTLE	TABLET	50	104
71335-1963-1	Sildenafil	10 in 1 BOTTLE	TABLET	10	104
71335-1963-2	Sildenafil	30 in 1 BOTTLE	TABLET	30	104
71335-1963-3	Sildenafil	7 in 1 BOTTLE	TABLET	7	104
71335-1963-4	Sildenafil	90 in 1 BOTTLE	TABLET	90	104
71335-1963-5	Sildenafil	60 in 1 BOTTLE	TABLET	60	104
71335-1963-6	Sildenafil	20 in 1 BOTTLE	TABLET	20	104
71335-1963-7	Sildenafil	270 in 1 BOTTLE	TABLET	270	104
71335-1963-8	Sildenafil	15 in 1 BOTTLE	TABLET	15	104
71335-1963-9	Sildenafil	12 in 1 BOTTLE	TABLET	12	104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1963	SILDENAFIL TABLET [BRYANT RANCH PREPACK]	104	Current NDC, Legacy NDC, 10 package rows	20240830_fe848310-57d8-4492-829c-3e2535754a55.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	REMEDYREPACK INC.	e4f41e9e-d508-4f91-8677-8a19b07139de	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	cc3656ac-3a38-a650-e053-2a95a90a912a	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394
Sildenafil	SILDENAFIL	Quallent Pharmaceuticals Health LLC	333ca682-931f-4edb-95d6-2edbd87631cf	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394
Sildenafil	SILDENAFIL	Ajanta Pharma USA Inc.	31c0f8ab-ed2e-4ead-a8c0-4055f6c43783	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394
Sildenafil	SILDENAFIL	Proficient Rx LP	7dd302cd-b84d-4d7d-bd1e-2916febbaea5	2025-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	d35f8d6b-e642-78bb-e053-2995a90abb2e	2025-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394
SILDENAFIL	SILDENAFIL	DirectRx	d1ee9139-13ac-7d5b-e053-2995a90a8e50	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394
Sildenafil	SILDENAFIL	Preferred Pharmaceuticals Inc.	d887377e-90c5-44dc-8455-b23a6755b36f	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	fe848310-57d8-4492-829c-3e2535754a55	2024-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210394 application number: ANDA210394 ndc (product): 71335-1963

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	fe848310-57d8-4492-829c-3e2535754a55	104
577033	sildenafil 20 MG Oral Tablet	SCD	fe848310-57d8-4492-829c-3e2535754a55	104
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	fe848310-57d8-4492-829c-3e2535754a55	104

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1963-0	71335196300	50 TABLET in 1 BOTTLE (71335-1963-0)	50 tablet	2022-02-14	0000-00-00	No	No	Current
71335-1963-1	71335196301	10 TABLET in 1 BOTTLE (71335-1963-1)	10 tablet	2022-02-14	0000-00-00	No	No	Current
71335-1963-2	71335196302	30 TABLET in 1 BOTTLE (71335-1963-2)	30 tablet	2021-10-06	0000-00-00	No	No	Current
71335-1963-3	71335196303	7 TABLET in 1 BOTTLE (71335-1963-3)	7 tablet	2022-02-14	0000-00-00	No	No	Current
71335-1963-4	71335196304	90 TABLET in 1 BOTTLE (71335-1963-4)	90 tablet	2021-11-22	0000-00-00	No	No	Current
71335-1963-5	71335196305	60 TABLET in 1 BOTTLE (71335-1963-5)	60 tablet	2022-02-14	0000-00-00	No	No	Current
71335-1963-6	71335196306	20 TABLET in 1 BOTTLE (71335-1963-6)	20 tablet	2021-11-29	0000-00-00	No	No	Current
71335-1963-7	71335196307	270 TABLET in 1 BOTTLE (71335-1963-7)	270 tablet	2022-02-14	0000-00-00	No	No	Current
71335-1963-8	71335196308	15 TABLET in 1 BOTTLE (71335-1963-8)	15 tablet	2022-02-14	0000-00-00	No	No	Current
71335-1963-9	71335196309	12 TABLET in 1 BOTTLE (71335-1963-9)	12 tablet	2022-02-14	0000-00-00	No	No	Current