TADALAFIL

Product NDC: 76519-1225
11-digit product format: 765191225
Labeler code: 76519
Product ID: 76519-1225_8c687cd7-bda4-f812-e053-2995a90abfdd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TADALAFIL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA090141
Marketing category: ANDA
Marketing start: 2019-05-21
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76519-1225		I	Inactivated by FDA	2026-09-14
excluded package	package	76519-1225	76519-1225-3	I	Inactivated by FDA	2026-09-14
excluded package	package	76519-1225	76519-1225-5	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 1 · 54 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	76519-1225-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76519-1225-3	`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	76519-1225-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76519-1225-3	`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	76519-1225-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76519-1225-3	`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	76519-1225-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76519-1225-3	`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	76519-1225-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76519-1225-3	`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	76519-1225-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76519-1225-3	`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	76519-1225-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	76519-1225-3	`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	76519-1225-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	76519-1225-3	`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	76519-1225-5	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	76519-1225-3	`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	76519-1225-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	76519-1225-3	`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	76519-1225-5	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	76519-1225-3	`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	76519-1225-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	76519-1225-3	`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	76519-1225-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	76519-1225-3	`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	76519-1225-5	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	76519-1225-3	`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	76519-1225-5	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	76519-1225-3	`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	76519-1225-5	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	76519-1225-3	`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	76519-1225-5	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	76519-1225-3	`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	76519-1225-5	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	76519-1225-3	`bd6a592717d7…`	`303034d00443…`

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	Approval date
A090141-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22
A090141-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22
A090141-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22
A090141-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090141-001	AB1
A090141-002	AB1
A090141-003	AB1
A090141-004	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090141-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090141-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090141-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090141-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090141-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090141-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090141-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090141-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090141-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090141-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090141-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090141-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090141-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090141-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090141-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090141-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090141-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090141-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090141-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090141-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090141-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090141-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090141-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090141-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090141-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090141-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090141-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090141-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090141-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090141-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090141-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090141-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090141-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090141-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090141-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090141-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090141-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2018-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090141-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2018-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090141-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2018-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090141-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2018-05-22	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	A090141-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090141-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090141-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090141-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090141-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090141-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090141-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090141-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090141-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090141-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090141-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090141-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090141-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090141-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090141-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090141-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090141-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090141-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090141-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090141-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090141-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090141-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090141-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090141-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090141-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090141-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090141-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090141-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090141-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090141-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090141-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090141-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090141-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090141-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090141-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090141-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090141-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090141-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090141-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090141-004	AB1	1	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090141-001	PC	2019-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090141-002	PC	2019-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090141-003	PC	2019-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090141-004	PC	2019-03-26	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A090141-001	PC	2019-03-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090141-002	PC	2019-03-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090141-003	PC	2019-03-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090141-004	PC	2019-03-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090141-001	PC	2019-03-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090141-002	PC	2019-03-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090141-003	PC	2019-03-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090141-004	PC	2019-03-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090141-001	PC	2019-03-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090141-002	PC	2019-03-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090141-003	PC	2019-03-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090141-004	PC	2019-03-26	`ea99ee380514…`

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
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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76519-1225-3	2022-01-28	C162847	48780-1	d6a99b39-ebe6-a426-e053-dadaa90af4c2	1225/1226/1227 TADALAFIL 5/10/20 MG
76519-1225-5	2022-01-28	C162847	48780-1	d6a99b39-ebe6-a426-e053-dadaa90af4c2	1225/1226/1227 TADALAFIL 5/10/20 MG

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76519-1225-3	TADALAFIL	30 in 1 BOTTLE	TABLET, FILM COATED	30		1
76519-1225-5	TADALAFIL	15 in 1 BOTTLE	TABLET, FILM COATED	15		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76519-1225	TADALAFIL TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 2 package rows	20190725_8c687cd7-bda3-f812-e053-2995a90abfdd.zip

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
484814	tadalafil 10 MG Oral Tablet	PSN	8c687cd7-bda3-f812-e053-2995a90abfdd	1
402019	tadalafil 20 MG Oral Tablet	PSN	8c687cd7-bda3-f812-e053-2995a90abfdd	1
403957	tadalafil 5 MG Oral Tablet	PSN	8c687cd7-bda3-f812-e053-2995a90abfdd	1
484814	tadalafil 10 MG Oral Tablet	SCD	8c687cd7-bda3-f812-e053-2995a90abfdd	1
402019	tadalafil 20 MG Oral Tablet	SCD	8c687cd7-bda3-f812-e053-2995a90abfdd	1
403957	tadalafil 5 MG Oral Tablet	SCD	8c687cd7-bda3-f812-e053-2995a90abfdd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76519-1225-3	76519122503	30 TABLET, FILM COATED in 1 BOTTLE (76519-1225-3)	2019-05-21	0000-00-00	No	No	Current
76519-1225-5	76519122505	15 TABLET, FILM COATED in 1 BOTTLE (76519-1225-5)	2019-05-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
1225/1226/1227 TADALAFIL 5/10/20 MG	H.J. Harkins Company, Inc.	2019-06-28	HUMAN PRESCRIPTION DRUG LABEL	1