SILDENAFIL CITRATE

Product NDC: 51655-794
11-digit product format: 516550794
Labeler code: 51655
Product ID: 51655-794_4a7b48ce-0f22-14dc-e063-6394a90a10a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SILDENAFIL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA091448
Marketing category: ANDA
Marketing start: 2022-01-20
Substance: SILDENAFIL CITRATE
Active strength: 100 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091448-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11
A091448-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11
A091448-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091448-001	AB
A091448-002	AB
A091448-003	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 4 · 126 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	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A091448-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091448-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091448-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091448-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091448-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091448-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091448-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091448-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091448-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091448-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091448-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091448-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091448-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091448-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091448-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091448-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091448-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091448-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091448-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091448-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091448-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091448-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091448-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091448-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091448-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091448-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091448-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091448-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091448-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091448-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091448-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091448-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091448-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091448-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091448-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091448-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091448-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091448-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091448-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091448-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: SILDENAFIL CITRATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SILDENAFIL CITRATE	100 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
314229	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
d9de0817-cac1-4ee5-e053-2a95a90a5fa7	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
51655-794-54	SILDENAFIL CITRATE	15 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	15		3
51655-794-87	SILDENAFIL CITRATE	6 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	6		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-794	SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	2	Current NDC, 2 package rows	20240727_d9de0817-cac1-4ee5-e053-2a95a90a5fa7.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	3522bdcc-8113-4562-8ca1-f3eb884beaea	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	PD-Rx Pharmaceuticals, Inc.	ace2bb56-4992-49fe-9311-535b12eea9b4	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	PD-Rx Pharmaceuticals, Inc.	78c4551c-b922-43c9-9a5a-66377ea07bc2	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Redpharm Drug	52614168-3a9e-335d-e063-6394a90ac27f	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	NuCare Pharmaceuticals, Inc.	36da8e3a-d17c-e42f-e063-6394a90a1ece	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Preferred Pharmaceuticals Inc.	5f9ff0bb-5634-437a-96eb-249b910c7e81	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Bryant Ranch Prepack	a05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d6	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Bryant Ranch Prepack	edb0919d-cbf1-4968-b0eb-342aa811c2ce	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Torrent Pharmaceuticals Limited	b48630b1-5208-4d00-b56f-21701f223758	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Northwind Health Company, LLC	d9de0817-cac1-4ee5-e053-2a95a90a5fa7	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448 ndc (product): 51655-794

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
314229	sildenafil citrate 100 MG Oral Tablet	PSN	d9de0817-cac1-4ee5-e053-2a95a90a5fa7	3
314229	sildenafil 100 MG Oral Tablet	SCD	d9de0817-cac1-4ee5-e053-2a95a90a5fa7	3
314229	sildenafil 100 MG (as sildenafil citrate) Oral Tablet	SY	d9de0817-cac1-4ee5-e053-2a95a90a5fa7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51655-794-54	51655079454	15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-794-54)	2022-01-20	No	No	Current
51655-794-87	51655079487	6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-794-87)	2022-01-20	No	No	Current