Prescription drug · ANDA
Prednisone NDC 59651-489
Prednisone 50 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-489-01 | 59651048901 | 100 TABLET in 1 BOTTLE (59651-489-01)Marketed from Mar 28, 2022 | |
| 59651-489-78 | 59651048978 | 10 BLISTER PACK in 1 CARTON (59651-489-78) / 10 TABLET in 1 BLISTER PACKMarketed from Mar 28, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- 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 59651-489_d957f055-4838-49e6-ae32-604fb3056bc4SPL ID d957f055-4838-49e6-ae32-604fb3056bc4SPL set ID b1ac4c92-e1fd-4015-b172-0932790ae019RxCUI 198145, 198146, 198148, 312615, 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
N459651048901followed by a unit qualifier and the quantityPackage 59651-0489-01. 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.
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 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2389 |
| Prednisone | Prednisone 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2356 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4243 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | QPharma, Inc. | 42708-195 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7935 |
| 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 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3641 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0479 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8819 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Redpharm Drug | 67296-2182 |
| Prednisone | Prednisone 2.5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8858 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7441 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-486 |
| Prednisone | Prednisone 2.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-485 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-840 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-487 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4560 |
| Prednisone | Prednisone 20 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-488 |
| Prednisone | Prednisone 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8898 |
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