Sildenafil Citrate

Product NDC: 68071-3592
Requested package NDC: 68071-3592-1
11-digit product format: 680713592
Labeler code: 68071
Product ID: 68071-3592_308be64f-e32f-b592-e063-6394a90a451b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA206401
Marketing category: ANDA
Marketing start: 2018-10-12
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: 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
A206401-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12
A206401-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12
A206401-003	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206401-001	AB
A206401-002	AB
A206401-003	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	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-10-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206401-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-10-12	`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	A206401-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206401-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206401-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206401-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206401-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206401-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206401-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206401-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206401-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206401-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206401-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206401-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206401-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206401-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206401-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206401-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206401-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206401-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206401-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206401-001	AB	1	`8072bd15b7f6…`

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil Citrate	SILDENAFIL	Bryant Ranch Prepack	824dcd79-bc82-4b3a-8028-3c1bca1a7a0a	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	fbe75c2c-0aff-9ade-e053-6394a90a1ea4	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	Quallent Pharmaceuticals Health LLC	41b67fd2-3d9a-49d6-88b8-285044b98dc1	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	Ajanta Pharma USA Inc.	2ccc6fa6-f8ae-4191-806f-a887244e516a	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	Preferred Pharmaceuticals Inc.	878b4c44-cddc-42cb-b9b5-911451ad1530	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	155c7549-b7d6-0c06-e063-6294a90ac65c	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401 ndc (package): 68071-3592-1 ndc (product): 68071-3592 ndc11 (package): 68071359201
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals, Inc.	1d614710-708e-f11c-e063-6394a90a05a5	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL CITRATE	NuCare Pharmaceuticals, Inc.	20ead8ca-7cec-2d80-e063-6394a90af548	2024-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	Advanced Rx of Tennessee, LLC	1ceb575b-2687-0456-e063-6394a90aa88a	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	1b1ab00d-de9c-4614-e063-6394a90afcde	2024-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	NuCare Pharmaceuticals,Inc.	0bb3eb8d-05cd-b4cd-e063-6294a90a94bb	2024-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	A-S Medication Solutions	bf1a22a2-6a69-46c9-933d-e474e88637e9	2023-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	b9b1d6ee-da42-4ef2-ab93-cd36d7f34150	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401
Sildenafil Citrate	SILDENAFIL	Asclemed USA, Inc.	0500a861-359f-4e12-beb5-0cac8cd6ae1c	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206401 application number: ANDA206401

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314228	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
155c7549-b7d6-0c06-e063-6294a90ac65c	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
68071-3592-1	Sildenafil Citrate	10 in 1 BOTTLE	TABLET, FILM COATED	10		2
68071-3592-9	Sildenafil Citrate	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3592	SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 2 package rows	20250321_155c7549-b7d6-0c06-e063-6294a90ac65c.zip

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
314228	sildenafil citrate 25 MG Oral Tablet	PSN	155c7549-b7d6-0c06-e063-6294a90ac65c	2
314228	sildenafil 25 MG Oral Tablet	SCD	155c7549-b7d6-0c06-e063-6294a90ac65c	2
314228	sildenafil 25 MG (as sildenafil citrate) Oral Tablet	SY	155c7549-b7d6-0c06-e063-6294a90ac65c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68071-3592-1	68071359201	10 TABLET, FILM COATED in 1 BOTTLE (68071-3592-1)	2025-03-17	No	No	Current