SILDENAFIL CITRATE

Product NDC: 72789-405
11-digit product format: 727890405
Labeler code: 72789
Product ID: 72789-405_31f6c2bb-9a5b-e2f0-e063-6294a90aace5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SILDENAFIL CITRATE
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA209302
Marketing category: ANDA
Marketing start: 2020-09-04
Substance: SILDENAFIL CITRATE
Active strength: 50 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209302-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25
A209302-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25
A209302-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209302-001	AB
A209302-002	AB
A209302-003	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 3 · 107 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	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	BX	2020-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	BX	2020-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	BX	2021-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 107 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	A209302-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209302-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209302-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209302-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209302-003	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209302-003	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209302-003	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209302-003	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209302-003	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209302-003	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209302-003	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209302-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209302-003	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209302-003	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209302-003	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209302-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209302-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILDENAFIL CITRATE	50 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
312950	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
dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1	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	Strength	SPL version
72789-405-15	SILDENAFIL CITRATE	15 in 1 BOTTLE, PLASTIC	TABLET	15		12
72789-405-30	SILDENAFIL CITRATE	30 in 1 BOTTLE, PLASTIC	TABLET	30		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-405-15	EA - Each	72789-405	4d76409e-b8ca-4755-b573-7751bdb72f2c	1	2024-07-12
72789-405-30	EA - Each	72789-405	0540a430-e818-4ae3-8d37-f9fbc1d6b67c	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-405	SILDENAFIL CITRATE TABLET [PD-RX PHARMACEUTICALS, INC.]	12	Current NDC, 2 package rows	20250406_dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	f1122baa-8dee-43fc-bd3d-501a55b696b3	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Umedica Laboratories USA Inc.	90477a51-63ba-43f4-a74b-4659a946093c	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	NIVAGEN PHARMACEUTICALS, INC.	5ac95dd0-57e4-495c-bf8d-b2e5bbe33e20	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Northstar Rx LLC	8127ff38-2761-49ec-8ce7-7f971f521cfb	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	8780c159-8b61-402b-afbe-64f5c85d3886	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	30ce6e7f-716e-4a68-a4fb-2bb2d34ed052	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	1add0cab-8873-4cd1-ab53-e05c4ac458b1	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	PD-Rx Pharmaceuticals, Inc.	dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1	2025-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302 ndc (product): 72789-405
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Advanced Rx of Tennessee, LLC	30cb7d6a-ce40-c794-e063-6294a90a6861	2025-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Preferred Pharmaceuticals Inc.	5846bff2-6a93-46a7-a547-04459c590814	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	A-S Medication Solutions	6d79946b-72a9-4d1b-a84b-9d1a679a82e2	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302
SILDENAFIL CITRATE	SILDENAFIL CITRATE	Proficient Rx LP	59b623bc-fbdd-4f32-8327-0d600763f429	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209302 application number: ANDA209302

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BW9B0ZE037	SILDENAFIL CITRATE	171599-83-0	SILDENAFIL CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312950	sildenafil citrate 50 MG Oral Tablet	PSN	dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1	12
312950	sildenafil 50 MG Oral Tablet	SCD	dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1	12
312950	sildenafil 50 MG (as sildenafil citrate) Oral Tablet	SY	dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-405-15	72789040515	15 TABLET in 1 BOTTLE, PLASTIC (72789-405-15)	15 tablet	2024-06-07	No	No	Current
72789-405-30	72789040530	30 TABLET in 1 BOTTLE, PLASTIC (72789-405-30)	30 tablet	2024-06-07	No	No	Current