Prescription drug · ANDA
Prednisone NDC 63629-2260
Prednisone 2.5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2260-1 | 63629226001 | 100 TABLET in 1 BOTTLE, PLASTIC (63629-2260-1)Marketed from Oct 9, 2024 |
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 — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040581
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63629-2260_39977070-eb96-4c0b-a9cd-f492a5cd6dd4SPL ID 39977070-eb96-4c0b-a9cd-f492a5cd6dd4SPL set ID 6c0376c4-87cf-40dc-b140-a6aac75b64f7RxCUI 198146UNII 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
N463629226001followed by a unit qualifier and the quantityPackage 63629-2260-01. 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 040581
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 2.5 mg/1 | TabletOral | Par Health USA, LLC | 0603-5336 |
| Prednisone | Prednisone 2.5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-197 |
| Prednisone | Prednisone 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1448 |