Prescription drug · ANDA
PredniSONE Tablets, USP, 10 mg (prednisone) NDC 63561-0121
Prednisone 10 mg/1 · Tablet · Oral · Granulation Technology, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63561-0121-1 | 63561012101 | 100 TABLET in 1 BOTTLE (63561-0121-1)Marketed from May 22, 2025 | |
| 63561-0121-2 | 63561012102 | 1000 TABLET in 1 BOTTLE (63561-0121-2)Marketed from May 22, 2025 | |
| 63561-0121-5 | 63561012105 | 500 TABLET in 1 BOTTLE (63561-0121-5)Marketed from May 22, 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 Tablets, USP, 10 mg
- Generic name (nonproprietary)
- prednisone
- Active ingredients
- Prednisone — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Granulation Technology, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212629
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63561-0121_3c696af0-7946-dd78-e063-6394a90a71ccSPL ID 3c696af0-7946-dd78-e063-6394a90a71ccSPL set ID a173fcbb-99be-4b3e-a3a4-4e9ae04ad83fRxCUI 198145, 312615, 312617UNII VB0R961HZTUPC 0363561012012, 0363561012210, 0363561012159
- 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
N463561012101followed by a unit qualifier and the quantityPackage 63561-0121-01. 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 AND USAGE 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212629
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 Tablets, USP, 20 mgprednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2486 |
| PredniSONE Tablets, USP, 20 mgprednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2938 |
| PredniSONE Tablets, USP, 20 mgprednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2737 |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2736 |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2752 |
| PredniSONE Tablets, USP, 5 mgprednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2753 |
| PredniSONE Tablets, USP, 20 mgprednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2754 |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2485 |
| PredniSONE Tablets, USP, 5 mgprednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2484 |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3044 |
| PredniSONE Tablets, USP, 5 mgprednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3042 |
| PredniSONE Tablets, USP, 5 mgprednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3043 |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-475 |
| PredniSONE Tablets, USP, 10 mgprednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3045 |
| PredniSONE Tablets, USP, 20 mgprednisone | Prednisone 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-473 |
| PredniSONE Tablets, USP, 20 mgprednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3046 |
| PredniSONE Tablets, USP, 5 mgprednisone | Prednisone 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-474 |
| PredniSONE Tablets, USP, 20 mgprednisone | Prednisone 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3047 |
| PredniSONE Tablets, USP, 5 mgprednisone | Prednisone 5 mg/1 | TabletOral | Granulation Technology, Inc. | 63561-0120 |
| PredniSONE Tablets, USP, 5 mgprednisone | Prednisone 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-498 |
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