Sildenafil

Product NDC: 68071-3743
Requested package NDC: 68071-3743-3
11-digit product format: 680713743
Labeler code: 68071
Product ID: 68071-3743_28f2a326-e32e-adf1-e063-6294a90aa7fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA203962
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203962-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11
A203962-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11
A203962-003	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
A203962-001	AB
A203962-002	AB
A203962-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A203962-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203962-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203962-003	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	A203962-001	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	A203962-002	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	A203962-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203962-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203962-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203962-003	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	A203962-001	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	A203962-002	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	A203962-003	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	A203962-001	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	A203962-002	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	A203962-003	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	A203962-001	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	A203962-002	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	A203962-003	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	A203962-001	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	A203962-002	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	A203962-003	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	A203962-001	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	A203962-002	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	A203962-003	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	A203962-001	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	A203962-002	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	A203962-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203962-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203962-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203962-003	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	A203962-001	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	A203962-002	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	A203962-003	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	A203962-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203962-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203962-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203962-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203962-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203962-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203962-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203962-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203962-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203962-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203962-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203962-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203962-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203962-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203962-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203962-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203962-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203962-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203962-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203962-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203962-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203962-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203962-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203962-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203962-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203962-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203962-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203962-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203962-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203962-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203962-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203962-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203962-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203962-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203962-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203962-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203962-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203962-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203962-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203962-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203962-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203962-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203962-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203962-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203962-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203962-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203962-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sildenafil
Listing expiration: 2026-12-31

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
28f2af84-f4d4-acfe-e063-6294a90ae128	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	Strength	SPL version
68071-3743-3	Sildenafil	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3743	SILDENAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]	1	Current NDC, 1 package rows	20241212_28f2af84-f4d4-acfe-e063-6294a90ae128.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	A-S Medication Solutions	a10b7ec1-bb59-4906-b32d-fbd2a17ed7a8	2026-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203962 application number: ANDA203962
Sildenafil	SILDENAFIL	A-S Medication Solutions	18bd4315-2446-415b-a6a3-991ba0035768	2026-05-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203962 application number: ANDA203962
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals, Inc.	2916e6c4-bc68-c4d6-e063-6394a90aba79	2025-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203962 application number: ANDA203962
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals,Inc.	41b2c017-53a0-c687-e063-6394a90a15b2	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203962 application number: ANDA203962
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals, Inc.	3314d14e-99eb-39e5-e063-6394a90aed94	2025-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203962 application number: ANDA203962
Sildenafil	SILDENAFIL	NuCare Pharmaceuticals, Inc.	28f2af84-f4d4-acfe-e063-6294a90ae128	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203962 application number: ANDA203962 ndc (package): 68071-3743-3 ndc (product): 68071-3743 ndc11 (package): 68071374303
Sildenafil	SILDENAFIL	Aurobindo Pharma Limited	363c1e77-e482-47b2-aa1e-851abd770aeb	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203962 application number: ANDA203962
Sildenafil	SILDENAFIL	Proficient Rx LP	61c3866e-401d-48b3-a0d2-1e24a33ab512	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203962 application number: ANDA203962

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	28f2af84-f4d4-acfe-e063-6294a90ae128	1
312950	sildenafil 50 MG Oral Tablet	SCD	28f2af84-f4d4-acfe-e063-6294a90ae128	1
312950	sildenafil 50 MG (as sildenafil citrate) Oral Tablet	SY	28f2af84-f4d4-acfe-e063-6294a90ae128	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3743-3	68071374303	30 TABLET, FILM COATED in 1 BOTTLE (68071-3743-3)	2024-12-10	No	No	Current