Prescription drug · ANDA
PredniSONE NDC 0054-9817
Prednisone 10 mg/1 · Tablet · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-9817-25 | 00054981725 | 100 TABLET in 1 BOTTLE (0054-9817-25)Marketed from Mar 23, 2020 | |
| 0054-9817-29 | 00054981729 | 500 TABLET in 1 BOTTLE (0054-9817-29)Marketed from Mar 23, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- PredniSONE
- Generic name (nonproprietary)
- prednisone
- Active ingredients
- Prednisone — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 080352
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0054-9817_249c4c6d-a058-489a-8f84-928c14bfd3f9SPL ID 249c4c6d-a058-489a-8f84-928c14bfd3f9SPL set ID 263ed4fa-3c29-4abb-9cb1-bc016bd34a05RxCUI 198145, 312615, 312617UNII VB0R961HZTUPC 0300549817252, 0300549828258, 0300549818259
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400054981725followed by a unit qualifier and the quantityPackage 00054-9817-25. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS Prednisone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may requir…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 080352
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| PredniSONE | Prednisone 5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-9828 |
| PredniSONE | Prednisone 2.5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-4742 |
| PredniSONE | Prednisone 10 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0017 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0481 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0480 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4271 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-796 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-968 |
| PredniSONE | Prednisone 2.5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-8740 |
| PredniSONE | Prednisone 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0018 |
| PredniSONE | Prednisone 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-726 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-8724 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-4728 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0068 |
| PredniSONE | Prednisone 1 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-4741 |
| PredniSONE | Prednisone 20 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-9818 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-355 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6621 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6619 |
| PredniSONE | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6623 |
Showing 20 of 24.