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NDC 68180-0283-01 SILDENAFIL 10 mg/mL Details
SILDENAFIL 10 mg/mL
SILDENAFIL is a ORAL POWDER, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is SILDENAFIL CITRATE.
MedlinePlus Drug Summary
Sildenafil (Viagra) is used to treat erectile dysfunction (impotence; inability to get or keep an erection) in men. Sildenafil (Revatio) is used to improve the ability to exercise in adults with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Children should not usually take sildenafil, but in some cases, a doctor may decide that sildenafil (Revatio) is the best medication to treat a child's condition. Sildenafil is in a class of medications called phosphodiesterase (PDE) inhibitors. Sildenafil treats erectile dysfunction by increasing blood flow to the penis during sexual stimulation. This increased blood flow can cause an erection. Sildenafil treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily. If you are taking sildenafil to treat erectile dysfunction, you should know that it does not cure erectile dysfunction or increase sexual desire. Sildenafil does not prevent pregnancy or the spread of sexually transmitted diseases such as human immunodeficiency virus (HIV).
Related Packages: 68180-0283-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sildenafil
Product Information
| NDC | 68180-0283 |
|---|---|
| Product ID | 68180-283_18727593-f734-4bd5-88eb-625779d35660 |
| Associated GPIs | |
| GCN Sequence Number | 069921 |
| GCN Sequence Number Description | sildenafil citrate SUSP RECON 10 MG/ML ORAL |
| HIC3 | B1D |
| HIC3 Description | PULM.ANTI-HTN,SEL.C-GMP PHOSPHODIESTERASE T5 INHIB |
| GCN | 33186 |
| HICL Sequence Number | 018084 |
| HICL Sequence Number Description | SILDENAFIL CITRATE |
| Brand/Generic | Generic |
| Proprietary Name | SILDENAFIL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sildenafil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | SILDENAFIL CITRATE |
| Labeler Name | Lupin Pharmaceuticals, Inc. |
| Pharmaceutical Class | Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA211638 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68180-0283-01 (68180028301)
| NDC Package Code | 68180-283-01 |
|---|---|
| Billing NDC | 68180028301 |
| Package | 1 BOTTLE in 1 CARTON (68180-283-01) / 112 mL in 1 BOTTLE |
| Marketing Start Date | 2022-09-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |