ENTADFI

Product NDC: 69681-125
Requested package NDC: 69681-125-30
11-digit product format: 696810125
Labeler code: 69681
Product ID: 69681-125_e788df3c-753e-4bf8-8289-d68f4f452038
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: finasteride and tadalafil
Dosage form: CAPSULE
Route: ORAL
Labeler: Veru Inc.
Application: NDA215423
Marketing category: NDA
Marketing start: 2021-12-12
Marketing end: 0000-00-00
Substance: FINASTERIDE; TADALAFIL
Active strength: 5 mg/1; mg/1
Pharmacologic classes: 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69681-125	69681-125-30	I	Inactivated by FDA		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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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

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
N215423-001	ENTADFI	FINASTERIDE; TADALAFIL	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL	AB	RLD, RS	2021-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL	AB	RLD, RS	2021-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL	AB	RLD, RS	2021-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL	AB	RLD, RS	2021-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL	AB	RLD, RS	2021-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD, RS	2021-12-09	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215423-001	ENTADFI	5MG;5MG	CAPSULE / ORAL		RLD	2021-12-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215423-001	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215423-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215423-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215423-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215423-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
b90b74cb-f6c8-3798-d11c-73b8768b278a	Product name	8	20250317
0fe0157c-95a7-4870-ae64-de9f3fa874ae	Product name	1	20250227
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
20ae0006-d78c-4dba-9e3e-6ae424841903	Product name	1	20250127
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b86a08b7-54cc-440b-ad4a-3e530ccd8324	Product name	6	20230421
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
7a02e74a-2844-42af-84a8-96bae57351cf	Product name	1	20230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96f	Product name	1	20220706
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d00474ae-23eb-a8eb-bf56-520e590cc6db	Product name	2	20170406
0f90664c-9d0e-f046-dc6a-73563cd8347e	Product name	2	20170405
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69681-125-30	2025-01-30	C162847	48780-1	2cef2736-6750-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ENTADFI safely and effectively. See full prescribing information for ENTADFI. ENTADFI™ (finasteride and tadalafil) capsules, for oral use Initial U.S. Approval: 2021
69681-125-90	2025-01-30	C162847	48780-1	2cef2736-6750-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ENTADFI safely and effectively. See full prescribing information for ENTADFI. ENTADFI™ (finasteride and tadalafil) capsules, for oral use Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69681-125-30	ENTADFI	30 in 1 BOTTLE	CAPSULE	30		2
69681-125-90	ENTADFI	90 in 1 BOTTLE	CAPSULE	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69681-125-30	EA - Each	69681-125	b62aae48-40cf-454a-9bc1-3a40931e322b	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69681-125	ENTADFI (FINASTERIDE AND TADALAFIL) CAPSULE [VERU INC.]	2	Legacy NDC, 2 package rows	20230113_112bf653-8322-4444-8d4d-03234b11c38c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57GNO57U7G	FINASTERIDE	98319-26-7	FINASTERIDE
742SXX0ICT	TADALAFIL	171596-29-5	TADALAFIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2587747	ENTADFI 5 MG / 5 MG Oral Capsule	PSN	112bf653-8322-4444-8d4d-03234b11c38c	2
2587741	finasteride 5 MG / tadalafil 5 MG Oral Capsule	PSN	112bf653-8322-4444-8d4d-03234b11c38c	2
2587747	finasteride 5 MG / tadalafil 5 MG Oral Capsule [Entadfi]	SBD	112bf653-8322-4444-8d4d-03234b11c38c	2
2587741	finasteride 5 MG / tadalafil 5 MG Oral Capsule	SCD	112bf653-8322-4444-8d4d-03234b11c38c	2
2587747	Entadfi (finasteride 5 MG / tadalafil 5 MG) Oral Capsule	SY	112bf653-8322-4444-8d4d-03234b11c38c	2
2587747	Entadfi 5 MG / 5 MG Oral Capsule	SY	112bf653-8322-4444-8d4d-03234b11c38c	2
2587741	FIN5C 5 MG / tadalafil 5 MG Oral Capsule	SY	112bf653-8322-4444-8d4d-03234b11c38c	2
2587747	FIN5C 5 MG / tadalafil 5 MG Oral Capsule [Entadfi]	SY	112bf653-8322-4444-8d4d-03234b11c38c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69681-125-30	69681012530	30 CAPSULE in 1 BOTTLE (69681-125-30)	30 capsule	2021-12-12	0000-00-00	No	No	Current