Tadalafil

Product NDC: 0093-3017
11-digit product format: 000933017
Labeler code: 0093
Product ID: 0093-3017_08e8069b-c417-4cb8-8423-ffc540232a6a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA090141
Marketing category: ANDA
Marketing start: 2018-09-27
Marketing end: 0000-00-00
Substance: TADALAFIL
Active strength: 5 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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
unfinished product	product	0093-3017		UNFINISHED	Active or certified unfinished drug listing	2026-09-14
unfinished package	package	0093-3017	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	2026-09-14
excluded product	product	0093-3017		D	Discontinued by firm	2026-09-14
excluded package	package	0093-3017	0093-3017-56	D	Discontinued by firm	2026-09-14
excluded package	package	0093-3017	0093-3017-65	D	Discontinued by firm	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 · 50 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-3017-65	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-3017-56	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-3017-56	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-3017-56	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-3017-56	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-3017-56	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-3017-56	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	0093-3017-99	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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…`

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TADALAFIL	5 mg/1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-3017-30	EA - Each	0093-3017	91c93d8e-815f-43f0-acee-0d68963d1491	1	2018-10-11
0093-3017-56	EA - Each	0093-3017	3aee2318-6bcc-46cb-94b4-8395af305fc2	1	2018-10-11
0093-3017-65	EA - Each	0093-3017	34913ee6-da0b-4653-93d3-a4350014a7ef	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-3017	TADALAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	16	Legacy NDC	20241211_247ec8fe-e44c-4341-b992-2d6fd6d5f2ba.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-3017-56	00093301756	30 TABLET, FILM COATED in 1 BOTTLE (0093-3017-56)		2018-09-27	0000-00-00	No	No	Current
0093-3017-65	00093301765	2 BLISTER PACK in 1 BOX (0093-3017-65) > 15 TABLET, FILM COATED in 1 BLISTER PACK (0093-3017-30)	2 blister pack	2018-09-27	0000-00-00	No	No	Current
0093-3017-99	00093301799	241950 TABLET, FILM COATED in 1 DRUM (0093-3017-99)		10-AUG-18				Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tadalafil	Teva Pharmaceuticals USA, Inc.	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	16
Tadalafil	AvKARE	2021-07-13	HUMAN PRESCRIPTION DRUG LABEL	3