TADALAFIL

Product NDC: 71455-597
11-digit product format: 714550597
Labeler code: 71455
Product ID: 71455-597_dbb0b75f-b92c-09d5-e053-2995a90a03cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TADALAFIL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: UNYTER ENTERPRISES
Application: ANDA209167
Marketing category: ANDA
Marketing start: 2019-03-27
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71455-597		I	Inactivated by FDA		2026-09-14
excluded package	package	71455-597	71455-597-10	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 · 30 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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`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	71455-597-10	`1332a3947898…`	`d4bfe170f9cd…`

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
A209167-001	TADALAFIL	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26
A209167-002	TADALAFIL	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26
A209167-003	TADALAFIL	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23
A209167-004	TADALAFIL	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209167-001	AB1
A209167-002	AB1
A209167-003	AB1
A209167-004	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 · 168 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	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-001	TADALAFIL	2.5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-002	TADALAFIL	5MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-003	TADALAFIL	10MG	TABLET / ORAL	AB1	2019-10-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-004	TADALAFIL	20MG	TABLET / ORAL	AB1	2019-03-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A209167-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209167-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209167-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209167-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209167-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209167-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209167-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209167-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209167-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209167-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209167-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209167-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209167-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209167-004	AB1	1	`5bbf6a4d5a75…`

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
71455-597-10	2024-01-30	C162847	48780-1	1030e365-6cab-111a-e063-dadaa90a10e2	dbb0b75f-b92b-09d5-e053-2995a90a03cf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71455-597-10	TADALAFIL	10 in 1 BOTTLE	TABLET, FILM COATED	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71455-597	TADALAFIL TABLET, FILM COATED [UNYTER ENTERPRISES]	1	Legacy NDC, 1 package rows	20220429_dbb0b75f-b92b-09d5-e053-2995a90a03cf.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tadalafil	TADALAFIL	A-S Medication Solutions	a6847ad6-3b5b-47e5-a3b5-04dc3182d72b	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Bryant Ranch Prepack	07567ae5-7345-4ab1-9b2c-c586c4da0427	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Bryant Ranch Prepack	aa8d165b-0c7d-497a-b56a-7c62ebc0a5d2	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Bryant Ranch Prepack	f8def23c-55ea-4796-9735-dbcb25104835	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Accord Healthcare Inc.	eedf3ad9-7d40-496d-b1a9-6200010c18e1	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Preferred Pharmaceuticals Inc.	affacb88-4af3-4ce9-961b-7fc37b169e9a	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Northwind Health Company, LLC	f3092f5a-b976-91ab-e053-2995a90a9b50	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Northwind Health Company, LLC	f317fe1e-d7c4-fb8b-e053-2a95a90a5445	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	cf35291b-b05b-1182-e053-2995a90a8dee	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	9f83ea2e-8ee8-ab6d-e053-2995a90a1e96	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	NuCare Pharmaceuticals,Inc.	a0acad71-8ae3-2827-e053-2995a90a20b3	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	7a105ef9-7129-4ce1-bd8d-ae316bf348e2	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	b539e862-d5d4-4989-a3dd-1eba66285d53	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	31c05a53-7282-46d0-81bd-108defe6fb38	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Proficient Rx LP	6fa9d4fa-86c9-4791-b28b-78e8b9341cea	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167
Tadalafil	TADALAFIL	Asclemed USA, Inc.	aba646fe-70c2-1abb-e053-2995a90aa16d	2022-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209167 application number: ANDA209167

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
402019	tadalafil 20 MG Oral Tablet	PSN	dbb0b75f-b92b-09d5-e053-2995a90a03cf	1
402019	tadalafil 20 MG Oral Tablet	SCD	dbb0b75f-b92b-09d5-e053-2995a90a03cf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71455-597-10	71455059710	10 TABLET, FILM COATED in 1 BOTTLE (71455-597-10)	2022-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TADALAFIL - UNYTER ENTERPRISES \| UNYTER ENTRPRISES	UNYTER ENTERPRISES \| UNYTER ENTRPRISES	2022-04-02	HUMAN PRESCRIPTION DRUG LABEL	1