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NDC 00054-3721-44 PredniSONE Intensol 5 mg/mL Details
PredniSONE Intensol 5 mg/mL
PredniSONE Intensol is a ORAL SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is PREDNISONE.
MedlinePlus Drug Summary
Prednisone is used alone or with other medications to treat the symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). Prednisone is also used to treat other conditions in patients with normal corticosteroid levels. These conditions include certain types of arthritis; severe allergic reactions; multiple sclerosis (a disease in which the nerves do not function properly); lupus (a disease in which the body attacks many of its own organs); and certain conditions that affect the lungs, skin, eyes, kidneys blood, thyroid, stomach, and intestines. Prednisone is also sometimes used to treat the symptoms of certain types of cancer. Prednisone is in a class of medications called corticosteroids. It works to treat patients with low levels of corticosteroids by replacing steroids that are normally produced naturally by the body. It works to treat other conditions by reducing swelling and redness and by changing the way the immune system works.
Related Packages: 00054-3721-44Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Prednisone
Product Information
| NDC | 00054-3721 |
|---|---|
| Product ID | 0054-3721_1cbd408d-9d88-4c28-b0f5-6045a3d2e1ae |
| Associated GPIs | 22100045001310 |
| GCN Sequence Number | 006745 |
| GCN Sequence Number Description | prednisone ORAL CONC 5 MG/ML ORAL |
| HIC3 | P5A |
| HIC3 Description | GLUCOCORTICOIDS |
| GCN | 27161 |
| HICL Sequence Number | 002879 |
| HICL Sequence Number Description | PREDNISONE |
| Brand/Generic | Brand |
| Proprietary Name | PredniSONE Intensol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | PredniSONE Intensol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION, CONCENTRATE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | PREDNISONE |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA088810 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00054-3721-44 (00054372144)
| NDC Package Code | 0054-3721-44 |
|---|---|
| Billing NDC | 00054372144 |
| Package | 30 mL in 1 BOTTLE, GLASS (0054-3721-44) |
| Marketing Start Date | 1985-02-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |