Sildenafil

Product NDC: 71205-088
Requested package NDC: 71205-088-90
11-digit product format: 712050088
Labeler code: 71205
Product ID: 71205-088_ebc2e212-b59d-464c-a0cd-ede59263c5da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077342
Marketing category: ANDA
Marketing start: 2017-12-11
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 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
A077342-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09
A077342-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09
A077342-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077342-001	AB
A077342-002	AB
A077342-003	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	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2016-03-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2016-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2016-03-09	`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	A077342-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077342-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077342-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077342-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077342-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077342-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077342-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077342-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077342-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077342-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077342-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077342-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077342-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077342-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077342-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077342-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077342-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077342-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077342-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077342-001	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
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
43a036a4-8a34-4411-ac8e-bf5063d67d48	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
ac996ae9-22a2-41c2-bb86-913c4aef95ad	Product name	1	20230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fc	Product name	9	20220613
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-088-10	Sildenafil	10 in 1 BOTTLE	TABLET, FILM COATED	10	5
71205-088-20	Sildenafil	20 in 1 BOTTLE	TABLET, FILM COATED	20	5
71205-088-30	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
71205-088-50	Sildenafil	50 in 1 BOTTLE	TABLET, FILM COATED	50	5
71205-088-60	Sildenafil	60 in 1 BOTTLE	TABLET, FILM COATED	60	5
71205-088-90	Sildenafil	90 in 1 BOTTLE	TABLET, FILM COATED	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-088-20	EA - Each	71205-088	fd80ed27-85ac-460e-94aa-9bc9b2890a39	1	2021-06-02
71205-088-30	EA - Each	71205-088	3d2a569f-737a-4dd8-9c5e-deb308937bbe	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-088	SILDENAFIL TABLET, FILM COATED [PROFICIENT RX LP]	5	Current NDC, Legacy NDC, 6 package rows	20210501_43a036a4-8a34-4411-ac8e-bf5063d67d48.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	f9ab796c-1912-4137-abec-e8336a850a58	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342
Sildenafil	SILDENAFIL	Teva Pharmaceuticals USA, Inc.	5cbac450-f336-45bd-8d10-9ecfd21866eb	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342
Sildenafil	SILDENAFIL	Proficient Rx LP	43a036a4-8a34-4411-ac8e-bf5063d67d48	2021-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342 ndc (package): 71205-088-90 ndc (product): 71205-088 ndc11 (package): 71205008890
Sildenafil	SILDENAFIL	Proficient Rx LP	94eb1f59-2a7d-4230-9ae6-69c34d083326	2020-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077342 application number: ANDA077342

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	43a036a4-8a34-4411-ac8e-bf5063d67d48	5
314229	sildenafil 100 MG Oral Tablet	SCD	43a036a4-8a34-4411-ac8e-bf5063d67d48	5
314229	sildenafil 100 MG (as sildenafil citrate) Oral Tablet	SY	43a036a4-8a34-4411-ac8e-bf5063d67d48	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-088-90	71205008890	90 TABLET, FILM COATED in 1 BOTTLE (71205-088-90)	2018-08-01	0000-00-00	No	No	Current