Prescription drug · ANDA
Methylprednisolone NDC 70518-2864
Methylprednisolone 4 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2864-0 | 70518286400 | 1 BLISTER PACK in 1 CARTON (70518-2864-0) / 21 TABLET in 1 BLISTER PACKMarketed from Aug 28, 2020 |
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)
- Methylprednisolone
- Generic name (nonproprietary)
- methylprednisolone
- Active ingredients
- Methylprednisolone — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204072
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70518-2864_4ab9a399-aea8-6c5a-e063-6294a90aa134SPL ID 4ab9a399-aea8-6c5a-e063-6294a90aa134SPL set ID 445e59a6-8886-48e7-8116-253a82144934RxCUI 259966, 762675UNII X4W7ZR7023
- 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
N470518286400followed by a unit qualifier and the quantityPackage 70518-2864-00. 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 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 204072
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 | Epic Pharma, LLC | 42806-400 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Sportpharm LLC | 85766-037 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0255 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5221 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Tianjin Tianyao Pharmaceuticals Co., Ltd. | 57582-101 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | PHOENIX RX LLC | 85509-1400 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Proficient Rx LP | 71205-453 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Direct_Rx | 72189-264 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-961 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7833 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0035 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-193 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Doc Rx | 69306-400 |