Sildenafil

Product NDC: 68071-2985
Requested package NDC: 68071-2985-3
11-digit product format: 680712985
Labeler code: 68071
Product ID: 68071-2985_2dcdd45a-556b-0b9f-e063-6394a90a8a3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA202023
Marketing category: ANDA
Marketing start: 2018-06-28
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: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2985	68071-2985-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2985	68071-2985-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2985	68071-2985-3	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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: 2026-12-31

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
f98d51a5-e3c8-2b6c-e053-6294a90ac146	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2985-3	2025-02-10	C162847	48780-1	2cef2736-a027-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
68071-2985-3	2025-01-30	C162847	48780-1	2cef2736-a027-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2985-3	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2985	SILDENAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 1 package rows	20250212_f98d51a5-e3c8-2b6c-e053-6294a90ac146.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
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 ndc (package): 68071-2985-3 ndc (product): 68071-2985 ndc11 (package): 68071298503

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	f98d51a5-e3c8-2b6c-e053-6294a90ac146	2
314229	sildenafil 100 MG Oral Tablet	SCD	f98d51a5-e3c8-2b6c-e053-6294a90ac146	2
314229	sildenafil 100 MG (as sildenafil citrate) Oral Tablet	SY	f98d51a5-e3c8-2b6c-e053-6294a90ac146	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-2985-3	68071298503	30 TABLET, FILM COATED in 1 BOTTLE (68071-2985-3)	2023-04-17	No	No	Current