Cialis

Product NDC: 43353-857
11-digit product format: 433530857
Labeler code: 43353
Product ID: 43353-857_1afa3b7e-517b-40fb-a0e2-95fdc60d9803
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA021368
Marketing category: NDA
Marketing start: 2003-11-26
Marketing end: 0000-00-00
Substance: TADALAFIL
Active strength: 20 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-857		I	Inactivated by FDA	2026-09-14
excluded package	package	43353-857	43353-857-02	I	Inactivated by FDA	2026-09-14
excluded package	package	43353-857	43353-857-04	I	Inactivated by FDA	2026-09-14
excluded package	package	43353-857	43353-857-06	I	Inactivated by FDA	2026-09-14
excluded package	package	43353-857	43353-857-12	I	Inactivated by FDA	2026-09-14

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 · 75 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	43353-857-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-857-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-857-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-857-02	`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	43353-857-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-857-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-857-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-857-02	`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	43353-857-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-857-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-857-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-857-02	`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	43353-857-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-857-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-857-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-857-02	`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	43353-857-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-857-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-857-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-857-02	`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	43353-857-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-857-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-857-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-857-02	`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	43353-857-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-857-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-857-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-857-02	`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	43353-857-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-857-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-857-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-857-02	`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	43353-857-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-857-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-857-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-857-02	`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	43353-857-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-857-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-857-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-857-02	`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	43353-857-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-857-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-857-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-857-02	`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	43353-857-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-857-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-857-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-857-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021368-001	CIALIS	TADALAFIL	5MG	TABLET / ORAL	AB1	RLD	2003-11-21
N021368-002	CIALIS	TADALAFIL	10MG	TABLET / ORAL	AB1	RLD	2003-11-21
N021368-003	CIALIS	TADALAFIL	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21
N021368-004	CIALIS	TADALAFIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2008-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021368-001	AB1
N021368-002	AB1
N021368-003	AB1

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021368-004	CIALIS	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2008-01-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021368-004	CIALIS	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2008-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021368-004	CIALIS	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2008-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-004	CIALIS	2.5MG	TABLET / ORAL		RLD	2008-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-001	CIALIS	5MG	TABLET / ORAL	AB1	RLD	2003-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-002	CIALIS	10MG	TABLET / ORAL	AB1	RLD	2003-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-003	CIALIS	20MG	TABLET / ORAL	AB1	RLD, RS	2003-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-004	CIALIS	2.5MG	TABLET / ORAL	AB1	RLD	2008-01-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021368-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021368-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021368-003	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021368-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021368-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021368-003	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021368-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021368-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021368-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021368-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021368-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021368-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021368-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021368-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021368-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021368-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021368-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021368-004	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021368-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021368-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021368-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021368-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021368-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021368-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021368-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021368-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021368-003	AB1	1	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021368-001	6943166	2020-04-26	U-1184		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-001	6943166	2020-04-26	U-614		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-001	6943166	2020-04-26	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-001	6943166*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	6943166	2020-04-26	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	6943166	2020-04-26	U-614		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	6943166*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	6943166	2020-04-26	U-614		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	7182958	2020-04-26	U-155	Drug product, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	6943166*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	7182958*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	6943166	2020-04-26	U-155		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	7182958	2020-04-26	U-155	Drug product, Delist requested	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	6943166*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	7182958*PED	2020-10-26		Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021368-001	6943166	2020-04-26	U-1184		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-001	6943166	2020-04-26	U-614		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-001	6943166	2020-04-26	U-155		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-001	6943166*PED	2020-10-26		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-002	6943166	2020-04-26	U-155		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-002	6943166	2020-04-26	U-614		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-002	6943166*PED	2020-10-26		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-003	6943166	2020-04-26	U-614		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-003	6943166*PED	2020-10-26		Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-004	6943166	2020-04-26	U-155		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-004	6943166*PED	2020-10-26		Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021368-001	6943166	2020-04-26	U-1184		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-001	6943166	2020-04-26	U-614		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-001	6943166	2020-04-26	U-155		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-001	6943166*PED	2020-10-26		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-002	6943166	2020-04-26	U-155		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-002	6943166	2020-04-26	U-614		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-002	6943166*PED	2020-10-26		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-003	6943166	2020-04-26	U-614		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-003	6943166*PED	2020-10-26		Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-004	6943166	2020-04-26	U-155		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021368-004	6943166*PED	2020-10-26		Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021368-001	6943166	2020-04-26	U-1184		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021368-001	6943166	2020-04-26	U-614		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021368-001	6943166	2020-04-26	U-155		`3f01610625f2…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021368-001	M-219	2021-02-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-001	PED	2021-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	M-219	2021-02-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-002	PED	2021-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	M-219	2021-02-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-003	PED	2021-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	M-219	2021-02-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021368-004	PED	2021-08-15	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021368-001	M-219	2021-02-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-001	PED	2021-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-002	M-219	2021-02-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-002	PED	2021-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-003	M-219	2021-02-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-003	PED	2021-08-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-004	M-219	2021-02-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021368-004	PED	2021-08-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-001	M-219	2021-02-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-001	PED	2021-08-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-002	M-219	2021-02-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-002	PED	2021-08-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-003	M-219	2021-02-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-003	PED	2021-08-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-004	M-219	2021-02-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021368-004	PED	2021-08-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021368-001	M-219	2021-02-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-001	PED	2021-08-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-002	M-219	2021-02-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-002	PED	2021-08-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-003	M-219	2021-02-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-003	PED	2021-08-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-004	M-219	2021-02-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021368-004	PED	2021-08-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021368-001	M-219	2021-02-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-001	PED	2021-08-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-002	M-219	2021-02-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-002	PED	2021-08-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-003	M-219	2021-02-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-003	PED	2021-08-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-004	M-219	2021-02-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021368-004	PED	2021-08-15	`8869cabd3fbd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b90b74cb-f6c8-3798-d11c-73b8768b278a	Product name	8	20250317
0fe0157c-95a7-4870-ae64-de9f3fa874ae	Product name	1	20250227
20ae0006-d78c-4dba-9e3e-6ae424841903	Product name	1	20250127
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
b86a08b7-54cc-440b-ad4a-3e530ccd8324	Product name	6	20230421
7a02e74a-2844-42af-84a8-96bae57351cf	Product name	1	20230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96f	Product name	1	20220706

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-857-02	These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003
43353-857-04	These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003
43353-857-06	These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003
43353-857-12	These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-857-02	Cialis	2 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	2	3
43353-857-04	Cialis	4 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	4	3
43353-857-06	Cialis	6 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	6	3
43353-857-12	Cialis	12 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	12	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-857-02	EA - Each	43353-857	315fd858-55be-4402-b7a4-ffe703b43b71	1	2014-04-03
43353-857-04	EA - Each	43353-857	1b006ed3-0dcb-46f1-a583-02714c78e8e6	1	2014-04-03
43353-857-06	EA - Each	43353-857	76bc1581-2821-476b-a515-ce5755eac209	1	2017-12-14
43353-857-12	EA - Each	43353-857	8aecb9f2-ae3f-4664-9a76-41c8f1522f26	1	2017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Tadalafil	ACTIVE INGREDIENT	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Tadalafil	ACTIVE MOIETY	742SXX0ICT	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Magnesium stearate	INACTIVE INGREDIENT	70097M6I30	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Triacetin	INACTIVE INGREDIENT	XHX3C3X673	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-857	CIALIS (TADALAFIL) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 4 package rows	20191221_1da40b7c-c96a-45d2-a3f2-fafad429afd6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cialis	TADALAFIL	Eli Lilly and Company	bcd8f8ab-81a2-4891-83db-24a0b0e25895	2026-06-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021368 application number: NDA021368

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
742SXX0ICT	TADALAFIL	171596-29-5	TADALAFIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
402097	Cialis 20 MG Oral Tablet	PSN	1da40b7c-c96a-45d2-a3f2-fafad429afd6	3
402019	tadalafil 20 MG Oral Tablet	PSN	1da40b7c-c96a-45d2-a3f2-fafad429afd6	3
402097	tadalafil 20 MG Oral Tablet [Cialis]	SBD	1da40b7c-c96a-45d2-a3f2-fafad429afd6	3
402019	tadalafil 20 MG Oral Tablet	SCD	1da40b7c-c96a-45d2-a3f2-fafad429afd6	3
402097	Cialis 20 MG Oral Tablet	SY	1da40b7c-c96a-45d2-a3f2-fafad429afd6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-857-02	43353085702	2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-857-02)	2013-07-25	0000-00-00	No	No	Current
43353-857-04	43353085704	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-857-04)	2013-07-24	0000-00-00	No	No	Current
43353-857-06	43353085706	6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-857-06)	2015-02-26	0000-00-00	No	No	Current
43353-857-12	43353085712	12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-857-12)	2015-02-26	0000-00-00	No	No	Current