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NDC 69681-0125-90 ENTADFI 5; 5 mg/1; mg/1 Details

ENTADFI 5; 5 mg/1; mg/1

ENTADFI is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Veru Inc.. The primary component is FINASTERIDE; TADALAFIL.

MedlinePlus Drug Summary

Finasteride (Proscar) is used alone or in combination with another medication (doxazosin [Cardura]) to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland). Finasteride is used to treat symptoms of BPH such as frequent and difficult urination and may reduce the chance of acute urinary retention (sudden inability to urinate). It also may decrease the chance that prostate surgery will be needed. Finasteride (Propecia) is also used to treat male pattern hair loss (gradual thinning of the hair on the scalp, leading to a receding hairline or balding on the top of the head in men.) Finasteride (Propecia) has not been shown to treat thinning hair at the temples and is not used to treat hair loss in women or children. Finasteride is in a class of medications called 5-alpha reductase inhibitors. Finasteride treats BPH by blocking the body's production of a male hormone that causes the prostate to enlarge. Finasteride treats male pattern hair loss by blocking the body's production of a male hormone in the scalp that stops hair growth.

Related Packages: 69681-0125-90
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Finasteride

Tadalafil (Cialis) is used to treat erectile dysfunction (ED, impotence; inability to get or keep an erection), and the symptoms of benign prostatic hyperplasia (BPH; an enlarged prostate) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency in adult men. Tadalafil (Adcirca) is used to improve the ability to exercise in people with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Tadalafil is in a class of medications called phosphodiesterase (PDE) inhibitors. It works to treat erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Tadalafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow more easily. If you are taking tadalafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire. Tadalafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).

Related Packages: 69681-0125-90
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tadalafil

Product Information

NDC	69681-0125
Product ID	69681-125_e788df3c-753e-4bf8-8289-d68f4f452038
Associated GPIs
GCN Sequence Number	082910
GCN Sequence Number Description	finasteride/tadalafil CAPSULE 5 MG-5 MG ORAL
HIC3	Q9E
HIC3 Description	BPH AGENT-5-ALPHA-REDUCTASE INH AND PDE5 INH COMB
GCN	51694
HICL Sequence Number	047719
HICL Sequence Number Description	FINASTERIDE/TADALAFIL
Brand/Generic	Brand
Proprietary Name	ENTADFI
Proprietary Name Suffix	n/a
Non-Proprietary Name	finasteride and tadalafil
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	5; 5
Active Ingredient Units	mg/1; mg/1
Substance Name	FINASTERIDE; TADALAFIL
Labeler Name	Veru Inc.
Pharmaceutical Class	5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA], Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA215423
Listing Certified Through	2024-12-31

Package

NDC 69681-0125-90 (69681012590)

Pricing Information	N/A
NDC Package Code	69681-125-90
Billing NDC	69681012590
Package	90 CAPSULE in 1 BOTTLE (69681-125-90)
Marketing Start Date	2021-12-12
NDC Exclude Flag	N