SILDENAFIL

Product NDC: 55801-339
11-digit product format: 558010339
Labeler code: 55801
Product ID: 55801-339_d97109d0-3d4e-471e-b91f-abda06395b7f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SILDENAFIL
Dosage form: TABLET
Route: ORAL
Labeler: Appco Pharma LLC
Application: ANDA207178
Marketing category: ANDA
Marketing start: 2023-10-05
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 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
A207178-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02
A207178-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02
A207178-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207178-001	AB
A207178-002	AB
A207178-003	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 3 · 114 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	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2020-03-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2020-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207178-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2020-03-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A207178-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207178-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207178-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207178-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207178-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207178-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207178-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207178-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207178-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207178-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207178-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207178-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207178-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207178-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207178-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207178-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207178-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207178-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207178-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207178-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207178-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207178-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: SILDENAFIL
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 · 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
df1cc749-caec-4bf0-aa4d-db9dcc5257c3	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
55801-339-01	SILDENAFIL	30 in 1 BOTTLE	TABLET	30	10
55801-339-02	SILDENAFIL	100 in 1 BOTTLE	TABLET	100	10
55801-339-03	SILDENAFIL	500 in 1 BOTTLE	TABLET	500	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55801-339	SILDENAFIL TABLET [APPCO PHARMA LLC]	9	Current NDC, 3 package rows	20231006_df1cc749-caec-4bf0-aa4d-db9dcc5257c3.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SILDENAFIL	SILDENAFIL	Appco Pharma LLC	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207178 application number: ANDA207178 ndc (product): 55801-339
SILDENAFIL	SILDENAFIL	Aphena Pharma Solutions - Tennessee, LLC	cdab7ef5-39cb-45cc-b2bf-5f634f2f5499	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207178 application number: ANDA207178
SILDENAFIL	SILDENAFIL	CIPLA USA INC.,	15372a7c-2935-48dc-a55a-8966719b50be	2023-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207178 application number: ANDA207178
SILDENAFIL	SILDENAFIL	Exelan Pharmaceuticals, Inc.	1883785c-a1a4-48fe-b722-afacf2875ca8	2022-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207178 application number: ANDA207178
SILDENAFIL	SILDENAFIL	Proficient Rx LP	7086e222-0f2b-4c02-84c0-4f8635c90993	2021-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207178 application number: ANDA207178

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	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	10
314228	sildenafil citrate 25 MG Oral Tablet	PSN	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	10
312950	sildenafil citrate 50 MG Oral Tablet	PSN	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	10
314229	sildenafil 100 MG Oral Tablet	SCD	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	10
314228	sildenafil 25 MG Oral Tablet	SCD	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	10
312950	sildenafil 50 MG Oral Tablet	SCD	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	10
314229	sildenafil 100 MG (as sildenafil citrate) Oral Tablet	SY	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	10
314228	sildenafil 25 MG (as sildenafil citrate) Oral Tablet	SY	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	10
312950	sildenafil 50 MG (as sildenafil citrate) Oral Tablet	SY	df1cc749-caec-4bf0-aa4d-db9dcc5257c3	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55801-339-01	55801033901	30 TABLET in 1 BOTTLE (55801-339-01)	30 tablet	2023-10-05	No	No	Current
55801-339-02	55801033902	100 TABLET in 1 BOTTLE (55801-339-02)	100 tablet	2023-10-05	No	No	Current
55801-339-03	55801033903	500 TABLET in 1 BOTTLE (55801-339-03)	500 tablet	2023-10-05	No	No	Current