Prescription drug · ANDA
MethylPREDNISolone NDC 0603-4593
Methylprednisolone 4 mg/1 · Tablet · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0603-4593-15 | 00603459315 | 1 DOSE PACK in 1 CARTON (0603-4593-15) / 21 TABLET in 1 DOSE PACKMarketed from Dec 22, 1998 | |
| 0603-4593-21 | 00603459321 | 100 TABLET in 1 BOTTLE, PLASTIC (0603-4593-21)Marketed from Dec 22, 1998 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- MethylPREDNISolone
- Generic name (nonproprietary)
- methylprednisolone
- Active ingredients
- Methylprednisolone — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040183
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0603-4593_61876830-b7d4-464d-b825-75e7a08627e3SPL ID 61876830-b7d4-464d-b825-75e7a08627e3SPL set ID c84cf5e6-746d-41fb-b3d8-2c0b8ba989afRxCUI 259966, 762675UNII X4W7ZR7023UPC 0306034593212
- 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
N400603459315followed by a unit qualifier and the quantityPackage 00603-4593-15. 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 Methylprednisolone 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 Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 040183
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 |
|---|---|---|---|---|
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | American Health Packaging | 68084-149 |
| MethylPREDNISolone | Methylprednisolone 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2218 |
| MethylPREDNISolone | Methylprednisolone 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2226 |
| MethylPREDNISolone | Methylprednisolone 4 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-649 |
| MethylPREDNISolone | Methylprednisolone 4 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1161 |