Prescription drug · ANDA
Prednisone NDC 80425-0479
Prednisone 5 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0479-1 | 8042504790180425047901 | 21 TABLET in 1 BOTTLE (80425-0479-1)Marketed from Mar 28, 2022 |
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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215672
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 80425-0479_2e62cf3e-2872-0d18-e063-6394a90a8957SPL ID 2e62cf3e-2872-0d18-e063-6394a90a8957SPL set ID 2e62cf2e-dcbf-c15e-e063-6294a90a8168RxCUI 312617UNII 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
N480425047901followed by a unit qualifier and the quantityPackage 80425-0479-01. 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: 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 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 re…
Excerpt only. Read the full label for complete information.
About NDC 80425-0479
- What is NDC 80425-0479?
- 80425-0479 is the product NDC for Prednisone, Prednisone 5 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Prednisone.
- What is the active ingredient?
- Prednisone.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Prednisone?
- 281 other product NDCs are listed under this name. See all Prednisone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Prednisone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| PredniSONE | Prednisone 10 mg/1 | TabletOral | Coupler LLC | 67046-1294 | 67046-1294-03 |
| PredniSONE | Prednisone 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4182 | 68788-4182-0168788-4182-0268788-4182-03+3 more |
| prednisone | Prednisone 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-069 | 87441-0069-01 |
| prednisone | Prednisone 50 mg/1 | TabletOral | Coupler LLC | 67046-1171 | 67046-1171-03 |
| prednisone | Prednisone 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2582 | 55154-2582-00 |
| prednisone | Prednisone 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4660 | 70518-4660-00 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Coupler LLC | 67046-1379 | 67046-1379-03 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2581 | 55154-2581-00 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4560 | 70518-4560-00 |
| prednisone | Prednisone 5 mg/1 | TabletOral | American Health Packaging | 60687-903 | 60687-0903-01 |
Other NDCs under ANDA 215672
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 20 mg/1 | TabletOral | QPharma, Inc. | 42708-195 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7441 |
| Prednisone | Prednisone 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7825 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7931 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7933 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7935 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-8083 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-8084 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-8087 |
| Prednisone | Prednisone 2.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-485 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-486 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-487 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-488 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-489 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-840 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Coupler LLC | 67046-1379 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Coupler LLC | 67046-1610 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Redpharm Drug | 67296-2182 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3641 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3721 |
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