Sildenafil

Product NDC: 60219-1751
Requested package NDC: 60219-1751-7
11-digit product format: 602191751
Labeler code: 60219
Product ID: 60219-1751_64d4569d-26f0-4120-bc1e-c8dc47dcb387
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA202023
Marketing category: ANDA
Marketing start: 2018-06-28
Substance: SILDENAFIL CITRATE
Active strength: 25 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
A202023-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27
A202023-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27
A202023-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202023-001	AB
A202023-002	AB
A202023-003	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	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202023-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-27	`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	A202023-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202023-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202023-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202023-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202023-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202023-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202023-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202023-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202023-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202023-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202023-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202023-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202023-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202023-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202023-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202023-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202023-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202023-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202023-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202023-001	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	25 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312950	Internal RxNorm lookup
314228	Internal RxNorm lookup
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
a1c3a2a2-8cf5-41c3-9c86-54290570d916	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
60219-1751-1	Sildenafil	100 in 1 BOTTLE	TABLET, FILM COATED	100	12
60219-1751-3	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30	12
60219-1751-7	Sildenafil	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60219-1751-3	EA - Each	60219-1751	3e75f1b4-b91e-485d-971c-79aecdd555fb	1	2018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60219-1751	SILDENAFIL TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]	12	Current NDC, Legacy NDC, 3 package rows	20231128_a1c3a2a2-8cf5-41c3-9c86-54290570d916.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	96ae6733-cef9-46cf-bf4e-5368201943bd	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202023 application number: ANDA202023
Sildenafil	SILDENAFIL	Bryant Ranch Prepack	dfe4f616-b5de-458c-a97b-ab860e32320c	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202023 application number: ANDA202023
Sildenafil	SILDENAFIL	Amneal Pharmaceuticals NY LLC	a1c3a2a2-8cf5-41c3-9c86-54290570d916	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202023 application number: ANDA202023 ndc (package): 60219-1751-7 ndc (product): 60219-1751 ndc11 (package): 60219175107
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	f98d51a5-e3c8-2b6c-e053-6294a90ac146	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202023 application number: ANDA202023

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	a1c3a2a2-8cf5-41c3-9c86-54290570d916	12
314228	sildenafil citrate 25 MG Oral Tablet	PSN	a1c3a2a2-8cf5-41c3-9c86-54290570d916	12
312950	sildenafil citrate 50 MG Oral Tablet	PSN	a1c3a2a2-8cf5-41c3-9c86-54290570d916	12
314229	sildenafil 100 MG Oral Tablet	SCD	a1c3a2a2-8cf5-41c3-9c86-54290570d916	12
314228	sildenafil 25 MG Oral Tablet	SCD	a1c3a2a2-8cf5-41c3-9c86-54290570d916	12
312950	sildenafil 50 MG Oral Tablet	SCD	a1c3a2a2-8cf5-41c3-9c86-54290570d916	12
314229	sildenafil 100 MG (as sildenafil citrate) Oral Tablet	SY	a1c3a2a2-8cf5-41c3-9c86-54290570d916	12
314228	sildenafil 25 MG (as sildenafil citrate) Oral Tablet	SY	a1c3a2a2-8cf5-41c3-9c86-54290570d916	12
312950	sildenafil 50 MG (as sildenafil citrate) Oral Tablet	SY	a1c3a2a2-8cf5-41c3-9c86-54290570d916	12
314228	sildenafil citrate 25 MG Oral Tablet	PSN	3095b2c2-d0f8-485a-aeda-ef950868c154	5
314228	sildenafil 25 MG Oral Tablet	SCD	3095b2c2-d0f8-485a-aeda-ef950868c154	5
314228	sildenafil 25 MG (as sildenafil citrate) Oral Tablet	SY	3095b2c2-d0f8-485a-aeda-ef950868c154	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
60219-1751-7	60219175107	1000 TABLET, FILM COATED in 1 BOTTLE (60219-1751-7)	2018-06-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sildenafil	Amneal Pharmaceuticals NY LLC	2026-07-06	HUMAN PRESCRIPTION DRUG LABEL	14
Sildenafil	A-S Medication Solutions	2021-04-15	HUMAN PRESCRIPTION DRUG LABEL	5