Sildenafil Citrate

Product NDC: 17856-8100
Requested package NDC: 17856-8100-5
11-digit product format: 178568100
Labeler code: 17856
Product ID: 17856-8100_948b14c0-62f6-423f-a718-7bee707ed00c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA204883
Marketing category: ANDA
Marketing start: 2019-07-29
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 20 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17856-8100	17856-8100-5	I	Inactivated by FDA		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204883-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB		2016-06-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204883-001	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 2 · 41 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	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204883-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2016-06-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A204883-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204883-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204883-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204883-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204883-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204883-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204883-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204883-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204883-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204883-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204883-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204883-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204883-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204883-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204883-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204883-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204883-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204883-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204883-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204883-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204883-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204883-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204883-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204883-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204883-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204883-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204883-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204883-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204883-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204883-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204883-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204883-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204883-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204883-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204883-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204883-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204883-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204883-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204883-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204883-001	AB	1	`cb3db0bc1861…`

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, Related label table
NDC	Related label
17856-8100-1	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
17856-8100-2	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
17856-8100-3	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
17856-8100-4	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
17856-8100-5	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	SPL version
17856-8100-1	Sildenafil Citrate	1 in 1 POUCH	TABLET, FILM COATED	1	2
17856-8100-1	Sildenafil Citrate	200 in 1 BOX	TABLET, FILM COATED	200	2
17856-8100-2	Sildenafil Citrate	200 in 1 BOX	TABLET, FILM COATED	200	2
17856-8100-2	Sildenafil Citrate	2 in 1 POUCH	TABLET, FILM COATED	2	2
17856-8100-3	Sildenafil Citrate	3 in 1 POUCH	TABLET, FILM COATED	3	2
17856-8100-3	Sildenafil Citrate	200 in 1 BOX	TABLET, FILM COATED	200	2
17856-8100-4	Sildenafil Citrate	4 in 1 POUCH	TABLET, FILM COATED	4	2
17856-8100-4	Sildenafil Citrate	200 in 1 BOX	TABLET, FILM COATED	200	2
17856-8100-5	Sildenafil Citrate	5 in 1 POUCH	TABLET, FILM COATED	5	2
17856-8100-5	Sildenafil Citrate	200 in 1 BOX	TABLET, FILM COATED	200	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-8100	SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORP.]	2	Legacy NDC, 10 package rows	20210121_f0fc8f9c-7173-4d51-a39a-49437e7e73ee.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil Citrate	SILDENAFIL	Northwind Health Company, LLC	471b8574-cb2a-1670-e063-6394a90a2a84	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883
Sildenafil Citrate	SILDENAFIL	Advagen Pharma Ltd	ce683bbc-a1d2-4f23-b3d1-d9333d91dc55	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883
Sildenafil Citrate	SILDENAFIL	Northwind Health Company, LLC	d9ddfd2a-1961-90f9-e053-2a95a90a7f9b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	88825206-1b91-4d95-876c-71100912d378	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883
Sildenafil Citrate	SILDENAFIL	TruPharma LLC	c8864c64-22ad-402b-a1e8-cfb53fa02e80	2020-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	9ebc1a11-3f4b-4eb3-89f5-f430a330887d	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204883 application number: ANDA204883

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
577033	sildenafil citrate 20 MG Oral Tablet	PSN	f0fc8f9c-7173-4d51-a39a-49437e7e73ee	2
577033	sildenafil 20 MG Oral Tablet	SCD	f0fc8f9c-7173-4d51-a39a-49437e7e73ee	2
577033	sildenafil 20 MG (as sildenafil citrate) Oral Tablet	SY	f0fc8f9c-7173-4d51-a39a-49437e7e73ee	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-8100-5	17856810005	200 POUCH in 1 BOX (17856-8100-5) > 5 TABLET, FILM COATED in 1 POUCH	200 pouch	2021-01-20	0000-00-00	No	No	Current