Prescription drug · ANDA
Prednisone NDC 70518-0305
Prednisone 5 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-0305-0 | 70518030500 | 21 TABLET in 1 BOX, UNIT-DOSE (70518-0305-0)Marketed from Mar 10, 2017 |
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
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040256
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70518-0305_59809716-c713-5de0-e063-6294a90a14baSPL ID 59809716-c713-5de0-e063-6294a90a14baSPL set ID 746b0bcd-122e-4ea8-a824-28415073a38eRxCUI 312617, 763181UNII 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
N470518030500followed by a unit qualifier and the quantityPackage 70518-0305-00. 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 040256
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 | A-S Medication Solutions | 50090-7023 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7024 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7025 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3564 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Par Health USA, LLC | 0603-5337 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6923 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2257 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2264 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | American Health Packaging | 60687-122 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | American Health Packaging | 60687-134 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-1001 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-1002 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1605 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Par Health USA, LLC | 0603-5338 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9551 |
| Prednisone | Prednisone 10 mg/1 | TabletOral | Proficient Rx LP | 63187-037 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2146 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Proficient Rx LP | 63187-066 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 67544-399 |
| Prednisone | Prednisone 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-0439 |