Prescription drug · ANDA
Prednisone NDC 80425-0105
Prednisone 20 mg/1 · Tablet · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0105-1 | 80425010501 | 20 TABLET in 1 BOTTLE (80425-0105-1)Marketed from Aug 29, 2001 | |
| 80425-0105-2 | 80425010502 | 10 TABLET in 1 BOTTLE (80425-0105-2)Marketed from Mar 30, 2023 | |
| 80425-0105-3 | 80425010503 | 15 TABLET in 1 BOTTLE (80425-0105-3)Marketed from May 16, 2023 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040362
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 80425-0105_2a99a80e-d067-27e6-e063-6294a90ae0feSPL ID 2a99a80e-d067-27e6-e063-6294a90ae0feSPL set ID b3dbff9f-610f-7782-e053-2a95a90a71c1RxCUI 312615UNII 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
N480425010501followed by a unit qualifier and the quantityPackage 80425-0105-01. 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)
3. Indications and Usage Section INDICATIONS Prednisone Tablets, USP 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 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 requi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040362
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 | NuCare Pharmaceuticals,Inc. | 66267-812 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-860 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-3137 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0193 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3143 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Proficient Rx LP | 63187-300 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-3354 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7124 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-3361 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Proficient Rx LP | 63187-807 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Proficient Rx LP | 63187-020 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-067 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-068 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0069 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-069 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0106 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5202 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-171 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 66267-172 |