ENTADFI

Product NDC
69681-125
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
b90b74cb-f6c8-3798-d11c-73b8768b278aProduct name820250317
0fe0157c-95a7-4870-ae64-de9f3fa874aeProduct name120250227
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
20ae0006-d78c-4dba-9e3e-6ae424841903Product name120250127
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b86a08b7-54cc-440b-ad4a-3e530ccd8324Product name620230421
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7a02e74a-2844-42af-84a8-96bae57351cfProduct name120230313
928d249c-35c3-4d88-a9ef-cf2f2e31b96fProduct name120220706
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d00474ae-23eb-a8eb-bf56-520e590cc6dbProduct name220170406
0f90664c-9d0e-f046-dc6a-73563cd8347eProduct name220170405
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69681-125-30ENTADFI30 in 1 BOTTLECAPSULE302
69681-125-90ENTADFI90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69681-125-30EA - Each69681-125b62aae48-40cf-454a-9bc1-3a40931e322b12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69681-125ENTADFI (FINASTERIDE AND TADALAFIL) CAPSULE [VERU INC.]2Legacy NDC, 2 package rows20230113_112bf653-8322-4444-8d4d-03234b11c38c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2587747ENTADFI 5 MG / 5 MG Oral CapsulePSN112bf653-8322-4444-8d4d-03234b11c38c2
2587741finasteride 5 MG / tadalafil 5 MG Oral CapsulePSN112bf653-8322-4444-8d4d-03234b11c38c2
2587747finasteride 5 MG / tadalafil 5 MG Oral Capsule [Entadfi]SBD112bf653-8322-4444-8d4d-03234b11c38c2
2587741finasteride 5 MG / tadalafil 5 MG Oral CapsuleSCD112bf653-8322-4444-8d4d-03234b11c38c2
2587747Entadfi (finasteride 5 MG / tadalafil 5 MG) Oral CapsuleSY112bf653-8322-4444-8d4d-03234b11c38c2
2587747Entadfi 5 MG / 5 MG Oral CapsuleSY112bf653-8322-4444-8d4d-03234b11c38c2
2587741FIN5C 5 MG / tadalafil 5 MG Oral CapsuleSY112bf653-8322-4444-8d4d-03234b11c38c2
2587747FIN5C 5 MG / tadalafil 5 MG Oral Capsule [Entadfi]SY112bf653-8322-4444-8d4d-03234b11c38c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69681-125-306968101253030 CAPSULE in 1 BOTTLE (69681-125-30) 30 capsule2021-12-120000-00-00NoNoCurrent
69681-125-906968101259090 CAPSULE in 1 BOTTLE (69681-125-90) 90 capsule2021-12-120000-00-00NoNoCurrent