SILDENAFIL CITRATE

Product NDC: 71335-3111
Requested package NDC: 71335-3111-6
11-digit product format: 713353111
Labeler code: 71335
Product ID: 71335-3111_8dfbbbc6-2ad4-4aaa-a7ec-17dc31e3efd3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SILDENAFIL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091448
Marketing category: ANDA
Marketing start: 2018-06-11
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A091448-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091448-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091448-003	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	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
a05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d6	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
71335-3111-1	SILDENAFIL CITRATE	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
71335-3111-2	SILDENAFIL CITRATE	10 in 1 BOTTLE	TABLET, FILM COATED	10	1
71335-3111-3	SILDENAFIL CITRATE	15 in 1 BOTTLE	TABLET, FILM COATED	15	1
71335-3111-4	SILDENAFIL CITRATE	90 in 1 BOTTLE	TABLET, FILM COATED	90	1
71335-3111-5	SILDENAFIL CITRATE	60 in 1 BOTTLE	TABLET, FILM COATED	60	1
71335-3111-6	SILDENAFIL CITRATE	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
71335-3111-7	SILDENAFIL CITRATE	7 in 1 BOTTLE	TABLET, FILM COATED	7	1
71335-3111-8	SILDENAFIL CITRATE	40 in 1 BOTTLE	TABLET, FILM COATED	40	1

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 ndc (package): 71335-3111-6 ndc (product): 71335-3111 ndc11 (package): 71335311106
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

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
312950	sildenafil citrate 50 MG Oral Tablet	PSN	a05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d6	1
312950	sildenafil 50 MG Oral Tablet	SCD	a05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d6	1
312950	sildenafil 50 MG (as sildenafil citrate) Oral Tablet	SY	a05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-3111-6	71335311106	20 TABLET, FILM COATED in 1 BOTTLE (71335-3111-6)	2026-03-30	No	No	Current