SILDENAFIL

Product NDC: 72189-298
11-digit product format: 721890298
Labeler code: 72189
Product ID: 72189-298_2c294bda-345a-ad0e-e063-6294a90a0304
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SILDENAFIL
Dosage form: TABLET
Route: ORAL
Labeler: DirectRx
Application: ANDA210394
Marketing category: ANDA
Marketing start: 2021-11-29
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-298-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-298-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-298-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-298-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-298-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-298-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-298-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-298-20	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210394-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2018-05-04	`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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210394-001	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
d1ee9139-13ac-7d5b-e053-2995a90a8e50	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
72189-298-15	SILDENAFIL	15 in 1 BOTTLE	TABLET	15	6
72189-298-20	SILDENAFIL	20 in 1 BOTTLE	TABLET	20	6
72189-298-30	SILDENAFIL	30 in 1 BOTTLE	TABLET	30	6
72189-298-90	SILDENAFIL	90 in 1 BOTTLE	TABLET	90	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-298-15	EA - Each	72189-298	5f4fb7ff-b88b-423c-8cbb-f41af8d7368f	1	2023-09-05
72189-298-20	EA - Each	72189-298	5c6905aa-2da0-4c0a-86b4-ad3bc99b68bd	1	2022-01-06
72189-298-30	EA - Each	72189-298	6dc54697-7e2f-47f9-b023-9cbb5c9fca6e	1	2022-09-12
72189-298-90	EA - Each	72189-298	0754b15d-ea89-49ac-9fdc-85dbca4d08c9	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-298	SILDENAFIL TABLET [DIRECTRX]	6	Current NDC, Legacy NDC, 4 package rows	20250121_d1ee9139-13ac-7d5b-e053-2995a90a8e50.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 ndc (product): 72189-298
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

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	d1ee9139-13ac-7d5b-e053-2995a90a8e50	6
577033	sildenafil 20 MG Oral Tablet	SCD	d1ee9139-13ac-7d5b-e053-2995a90a8e50	6
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	d1ee9139-13ac-7d5b-e053-2995a90a8e50	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-298-15	72189029815	15 TABLET in 1 BOTTLE (72189-298-15)	15 tablet	2021-11-29		No	No	Current
72189-298-20	72189029820	20 TABLET in 1 BOTTLE (72189-298-20)	20 tablet	2021-11-29	0000-00-00	No	No	Current
72189-298-30	72189029830	30 TABLET in 1 BOTTLE (72189-298-30)	30 tablet	2022-07-28	0000-00-00	No	No	Current
72189-298-90	72189029890	90 TABLET in 1 BOTTLE (72189-298-90)	90 tablet	2021-11-29	0000-00-00	No	No	Current