Tadalafil

Product NDC: 70518-2862
11-digit product format: 705182862
Labeler code: 70518
Product ID: 70518-2862_d773fd82-b72d-1678-e053-2a95a90acefd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tadalafil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA210145
Marketing category: ANDA
Marketing start: 2020-08-26
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: 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70518-2862		D	Discontinued by firm	2026-09-14
excluded package	package	70518-2862	70518-2862-0	D	Discontinued by firm	2026-09-14
excluded package	package	70518-2862	70518-2862-1	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 · 33 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	70518-2862-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2862-0	`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	70518-2862-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2862-0	`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	70518-2862-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70518-2862-0	`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	70518-2862-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70518-2862-0	`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	70518-2862-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70518-2862-0	`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	70518-2862-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70518-2862-0	`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	70518-2862-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70518-2862-0	`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	70518-2862-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70518-2862-0	`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	70518-2862-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70518-2862-0	`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	70518-2862-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70518-2862-0	`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	70518-2862-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70518-2862-0	`367a005e9d99…`	`383a685ebd0f…`

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

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
A210145-001	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB2		2019-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210145-001	AB2

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 · 43 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	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210145-001	TADALAFIL	20MG	TABLET / ORAL	AB2	2019-02-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A210145-001	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210145-001	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210145-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210145-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210145-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210145-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210145-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210145-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210145-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210145-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210145-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210145-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210145-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210145-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210145-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210145-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210145-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210145-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210145-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210145-001	AB2	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210145-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210145-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210145-001	AB2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210145-001	AB2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210145-001	AB2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210145-001	AB2	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210145-001	AB2	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210145-001	AB2	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210145-001	AB2	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210145-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210145-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210145-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210145-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210145-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210145-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210145-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210145-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210145-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210145-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210145-001	AB2	1	`f41ea6bd6efb…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2862-0	2022-02-07	C162847	48780-1	d6a99b39-4606-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral administration Initial U.S. Approval: 2003
70518-2862-0	2022-01-28	C162847	48780-1	d6a99b39-4606-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral administration Initial U.S. Approval: 2003

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
Tadalafil	TADALAFIL	Dr.Reddys Laboratories Inc	61955171-ca57-e300-1983-9472a56ca976	2020-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210145 application number: ANDA210145

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
70518-2862-0	70518286200	12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2862-0)	2020-08-26	0000-00-00	No	No	Current
70518-2862-1	70518286201	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2862-1)	2021-12-09	0000-00-00	No	No	Current