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NDC 71610-0581-12 Tadalafil 10 mg/1 Details
Tadalafil 10 mg/1
Tadalafil is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, LLC. The primary component is TADALAFIL.
MedlinePlus Drug Summary
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: 71610-0581-12Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tadalafil
Product Information
| NDC | 71610-0581 |
|---|---|
| Product ID | 71610-581_8d4b2e53-8d7c-4c86-a25f-8c144a5c542c |
| Associated GPIs | 40304080000310 |
| GCN Sequence Number | 051656 |
| GCN Sequence Number Description | tadalafil TABLET 10 MG ORAL |
| HIC3 | F2A |
| HIC3 Description | DRUGS TO TREAT ERECTILE DYSFUNCTION (ED) |
| GCN | 18995 |
| HICL Sequence Number | 024859 |
| HICL Sequence Number Description | TADALAFIL |
| Brand/Generic | Generic |
| Proprietary Name | Tadalafil |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tadalafil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | TADALAFIL |
| Labeler Name | Aphena Pharma Solutions - Tennessee, LLC |
| Pharmaceutical Class | Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209744 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71610-0581-12 (71610058112)
| NDC Package Code | 71610-581-12 |
|---|---|
| Billing NDC | 71610058112 |
| Package | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-581-12) |
| Marketing Start Date | 2021-07-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |