SILDENAFIL CITRATE

Product NDC: 72789-405
Requested package NDC: 72789-405-15
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 2 · 50 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
2021-05-05 16:15 UTC	2021-05	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`87673890dc5c…`
2021-05-05 16:15 UTC	2021-05	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209302-003	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2021-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209302-001	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-08-25	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A209302-002	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-08-25	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC	2021-05	A209302-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC	2021-05	A209302-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209302-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209302-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209302-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209302-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209302-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209302-002	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209302-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209302-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209302-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209302-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209302-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209302-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209302-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209302-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209302-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209302-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209302-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209302-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209302-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209302-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209302-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209302-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209302-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209302-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209302-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209302-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209302-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209302-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209302-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209302-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209302-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209302-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209302-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209302-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209302-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209302-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209302-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A209302-002	AB	1	`f41ea6bd6efb…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 72789-405-15 ndc (product): 72789-405 ndc11 (package): 72789040515
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

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

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