Tadalafil

Product NDC: 68462-782
11-digit product format: 684620782
Labeler code: 68462
Product ID: 68462-782_ab4a5677-ee15-46d1-888c-58727a949aa5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: GLENMARK PHARMACEUTICALS INC., USA
Application: ANDA210716
Marketing category: ANDA
Marketing start: 2020-12-29
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: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68462-782		D	Discontinued by firm	2026-08-03
excluded package	package	68462-782	68462-782-30	D	Discontinued by firm	2026-08-03
excluded package	package	68462-782	68462-782-60	D	Discontinued by firm	2026-08-03
excluded package	package	68462-782	68462-782-90	D	Discontinued by firm	2026-08-03

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 · 48 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	68462-782-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68462-782-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68462-782-60	`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	68462-782-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68462-782-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68462-782-60	`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	68462-782-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68462-782-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68462-782-60	`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	68462-782-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68462-782-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68462-782-60	`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	68462-782-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68462-782-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68462-782-60	`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	68462-782-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68462-782-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68462-782-60	`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	68462-782-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68462-782-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68462-782-60	`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	68462-782-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68462-782-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68462-782-60	`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	68462-782-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68462-782-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68462-782-60	`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	68462-782-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68462-782-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68462-782-60	`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	68462-782-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68462-782-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68462-782-60	`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	68462-782-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68462-782-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68462-782-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	Approval date
A210716-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29
A210716-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	2020-12-29
A210716-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	2020-12-29
A210716-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	2020-12-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210716-001	TADALAFIL	2.5MG	TABLET / ORAL	2020-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210716-002	TADALAFIL	5MG	TABLET / ORAL	2020-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210716-003	TADALAFIL	10MG	TABLET / ORAL	2020-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210716-004	TADALAFIL	20MG	TABLET / ORAL	2020-12-29	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	A210716-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210716-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210716-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210716-004	AB1	1	`5aa47cf7b7d7…`

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	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-782-30	68462078230	30 TABLET, FILM COATED in 1 BOTTLE (68462-782-30)	2020-12-29	0000-00-00	No	No	Current
68462-782-60	68462078260	60 TABLET, FILM COATED in 1 BOTTLE (68462-782-60)	2020-12-29	0000-00-00	No	No	Current
68462-782-90	68462078290	90 TABLET, FILM COATED in 1 BOTTLE (68462-782-90)	2020-12-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tadalafil	GLENMARK PHARMACEUTICALS INC., USA \| Glenmark Pharmaceuticals Limited	2019-08-08	HUMAN PRESCRIPTION DRUG LABEL	2