Sildenafil Citrate

Product NDC: 45865-937
11-digit product format: 458650937
Labeler code: 45865
Product ID: 45865-937_7df35d1d-0eea-4933-e053-2991aa0ace33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA091448
Marketing category: ANDA
Marketing start: 2017-12-11
Marketing end: 0000-00-00
Substance: SILDENAFIL CITRATE
Active strength: 100 1/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45865-937		I	Inactivated by FDA		2026-08-11
excluded package	package	45865-937	45865-937-30	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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45865-937-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45865-937-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45865-937-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45865-937-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45865-937-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45865-937-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45865-937-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45865-937-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45865-937-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	45865-937-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	45865-937-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	45865-937-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	45865-937-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	45865-937-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	45865-937-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	45865-937-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	45865-937-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	45865-937-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	45865-937-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	45865-937-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	45865-937-30	`9bebd1f3094a…`	`5416666fcb17…`

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
A091448-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11
A091448-002	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11
A091448-003	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
A091448-001	AB
A091448-002	AB
A091448-003	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	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091448-003	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	A091448-001	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	A091448-002	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	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091448-003	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	A091448-001	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	A091448-002	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	A091448-003	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	A091448-001	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	A091448-002	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	A091448-003	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	A091448-001	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	A091448-002	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	A091448-003	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	A091448-001	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	A091448-002	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	A091448-003	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	A091448-001	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	A091448-002	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	A091448-003	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	A091448-001	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	A091448-002	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	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091448-001	SILDENAFIL CITRATE	EQ 25MG BASE	TABLET / ORAL	AB	2018-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091448-002	SILDENAFIL CITRATE	EQ 50MG BASE	TABLET / ORAL	AB	2018-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091448-003	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	A091448-001	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	A091448-002	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	A091448-003	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	A091448-001	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	A091448-002	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	A091448-003	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	A091448-001	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	A091448-002	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	A091448-003	SILDENAFIL CITRATE	EQ 100MG BASE	TABLET / ORAL	AB	2018-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091448-001	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	A091448-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091448-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091448-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091448-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091448-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091448-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091448-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091448-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091448-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091448-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091448-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091448-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091448-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091448-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091448-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091448-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091448-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091448-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091448-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091448-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091448-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091448-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091448-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091448-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091448-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091448-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091448-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091448-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091448-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091448-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091448-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091448-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091448-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091448-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091448-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091448-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091448-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091448-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091448-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091448-001	AB	1	`8072bd15b7f6…`

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
45865-937-30	2020-01-31	C162847	48780-1	9d75b9d0-1ca5-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS Initial U.S. Approval:1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45865-937-30	Sildenafil Citrate	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
45865-937	SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 1 package rows	20181227_7df35d1d-0ee9-4933-e053-2991aa0ace33.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil Citrate	SILDENAFIL	Proficient Rx LP	3522bdcc-8113-4562-8ca1-f3eb884beaea	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	PD-Rx Pharmaceuticals, Inc.	ace2bb56-4992-49fe-9311-535b12eea9b4	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	PD-Rx Pharmaceuticals, Inc.	78c4551c-b922-43c9-9a5a-66377ea07bc2	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Redpharm Drug	52614168-3a9e-335d-e063-6394a90ac27f	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	NuCare Pharmaceuticals, Inc.	36da8e3a-d17c-e42f-e063-6394a90a1ece	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Preferred Pharmaceuticals Inc.	5f9ff0bb-5634-437a-96eb-249b910c7e81	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Bryant Ranch Prepack	a05ab4e7-6f70-41c3-a3b7-9a2fd7a1d2d6	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Bryant Ranch Prepack	edb0919d-cbf1-4968-b0eb-342aa811c2ce	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Torrent Pharmaceuticals Limited	b48630b1-5208-4d00-b56f-21701f223758	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448
SILDENAFIL CITRATE	SILDENAFIL	Northwind Health Company, LLC	d9de0817-cac1-4ee5-e053-2a95a90a5fa7	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091448 application number: ANDA091448

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	7df35d1d-0ee9-4933-e053-2991aa0ace33	1
314229	sildenafil 100 MG Oral Tablet	SCD	7df35d1d-0ee9-4933-e053-2991aa0ace33	1
314229	sildenafil 100 MG (as sildenafil citrate) Oral Tablet	SY	7df35d1d-0ee9-4933-e053-2991aa0ace33	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
45865-937-30	45865093730	30 in 1 BOTTLE	Historical