Prescription drug · ANDA
PredniSONE NDC 70518-4191
Prednisone 10 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4191-1 | 70518419101 | 30 TABLET in 1 BOTTLE, PLASTIC (70518-4191-1)Marketed from Sep 30, 2024 | |
| 70518-4191-3 | 70518419103 | 10 TABLET in 1 BOTTLE, PLASTIC (70518-4191-3)Marketed from Nov 6, 2024 | |
| 70518-4191-4 | 70518419104 | 18 TABLET in 1 BOTTLE, PLASTIC (70518-4191-4)Marketed from Apr 14, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 084122
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70518-4191_5a57b046-29fc-9114-e063-6294a90a6c17SPL ID 5a57b046-29fc-9114-e063-6294a90a6c17SPL set ID 94715919-70bd-46c9-95fc-e151adf39cf9RxCUI 198145UNII VB0R961HZT
- 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
N470518419101followed by a unit qualifier and the quantityPackage 70518-4191-01. 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 084122
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 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-493 |
| PredniSONE | Prednisone 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0485 |
| PredniSONE | Prednisone 10 mg/1 | TabletOral | QPharma, Inc. | 42708-045 |