Sildenafil

Product NDC: 71335-0288
11-digit product format: 713350288
Labeler code: 71335
Product ID: 71335-0288_6f673131-809f-411e-ae5d-92fb4e1600d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sildenafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078380
Marketing category: ANDA
Marketing start: 2013-05-31
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: 2021-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-0288		D	Discontinued by firm	2026-08-17
excluded package	package	71335-0288	71335-0288-1	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0288	71335-0288-2	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0288	71335-0288-3	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0288	71335-0288-4	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0288	71335-0288-5	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0288	71335-0288-6	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0288	71335-0288-7	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0288	71335-0288-8	D	Discontinued by firm	2026-08-17
excluded package	package	71335-0288	71335-0288-9	D	Discontinued by firm	2026-08-17

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 2 · 120 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	71335-0288-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0288-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0288-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0288-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0288-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0288-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0288-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0288-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-0288-3	`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	71335-0288-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0288-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0288-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0288-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0288-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0288-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0288-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0288-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-0288-3	`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	71335-0288-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0288-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0288-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0288-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0288-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0288-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0288-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0288-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-0288-3	`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	71335-0288-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0288-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0288-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0288-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0288-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0288-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0288-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0288-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-0288-3	`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	71335-0288-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0288-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0288-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0288-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0288-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0288-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0288-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0288-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-0288-3	`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	71335-0288-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0288-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0288-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0288-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0288-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0288-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0288-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0288-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-0288-3	`cdf11ea48f46…`	`ba0047e9e063…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078380-001	SILDENAFIL CITRATE	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL			2013-01-07

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 · 42 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
2026-08-18 06:07:40	2026-07	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL		2013-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078380-001	SILDENAFIL CITRATE	EQ 20MG BASE	TABLET / ORAL	AB	2013-01-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078380-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078380-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078380-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078380-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078380-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078380-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078380-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078380-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078380-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078380-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078380-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078380-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078380-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078380-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078380-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078380-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078380-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078380-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078380-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078380-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078380-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078380-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078380-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078380-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078380-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078380-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078380-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078380-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078380-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078380-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078380-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078380-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078380-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078380-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078380-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078380-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078380-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078380-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078380-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078380-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0288-1	EA - Each	71335-0288	18e47803-e15e-41e9-b7cf-185b0cd335c0	1	2018-04-19
71335-0288-2	EA - Each	71335-0288	f0639627-7741-4ed3-8adb-d5c51271752c	1	2018-04-19
71335-0288-4	EA - Each	71335-0288	7d8e8fba-542b-44b4-913f-327ed30fe9d0	1	2018-07-03
71335-0288-6	EA - Each	71335-0288	641c2dff-8176-45ef-aa3b-b2ed5e7caef8	1	2018-09-05

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sildenafil	SILDENAFIL	Proficient Rx LP	72c1516f-8a0c-495c-b11f-93bdc574ad21	2020-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078380 application number: ANDA078380

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0288-1	71335028801	10 TABLET, FILM COATED in 1 BOTTLE (71335-0288-1)	2013-05-31	0000-00-00	No	No	Current
71335-0288-2	71335028802	30 TABLET, FILM COATED in 1 BOTTLE (71335-0288-2)	2013-05-31	0000-00-00	No	No	Current
71335-0288-3	71335028803	7 TABLET, FILM COATED in 1 BOTTLE (71335-0288-3)	2013-05-31	0000-00-00	No	No	Current
71335-0288-4	71335028804	90 TABLET, FILM COATED in 1 BOTTLE (71335-0288-4)	2013-05-31	0000-00-00	No	No	Current
71335-0288-5	71335028805	60 TABLET, FILM COATED in 1 BOTTLE (71335-0288-5)	2013-05-31	0000-00-00	No	No	Current
71335-0288-6	71335028806	20 TABLET, FILM COATED in 1 BOTTLE (71335-0288-6)	2013-05-31	0000-00-00	No	No	Current
71335-0288-7	71335028807	270 TABLET, FILM COATED in 1 BOTTLE (71335-0288-7)	2013-05-31	0000-00-00	No	No	Current
71335-0288-8	71335028808	15 TABLET, FILM COATED in 1 BOTTLE (71335-0288-8)	2013-05-31	0000-00-00	No	No	Current
71335-0288-9	71335028809	12 TABLET, FILM COATED in 1 BOTTLE (71335-0288-9)	2013-05-31	0000-00-00	No	No	Current