Prescription drug · ANDA
methylprednisolone NDC 68382-919
Methylprednisolone 32 mg/1 · Tablet · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-919-01 | 68382091901 | 100 TABLET in 1 BOTTLE (68382-919-01)Marketed from May 1, 2018 | |
| 68382-919-05 | 68382091905 | 500 TABLET in 1 BOTTLE (68382-919-05)Marketed from May 1, 2018 | |
| 68382-919-11 | 68382091911 | 25 TABLET in 1 BOTTLE (68382-919-11)Marketed from May 1, 2018 | |
| 68382-919-77 | 68382091977 | 10 BLISTER PACK in 1 CARTON (68382-919-77) / 10 TABLET in 1 BLISTER PACK (68382-919-30)Marketed from May 1, 2018 |
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)
- methylprednisolone
- Generic name (nonproprietary)
- methylprednisolone
- Active ingredients
- Methylprednisolone — 32 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206751
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68382-919_6cebff10-362f-41a7-8f66-3d9e878760fdSPL ID 6cebff10-362f-41a7-8f66-3d9e878760fdSPL set ID eaa9c932-c659-4ef6-bf5a-186545d87320RxCUI 197971, 197973, 259966, 328161, 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
N468382091901followed by a unit qualifier and the quantityPackage 68382-0919-01. 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 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 l…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206751
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 | Major Pharmaceuticals | 0904-6914 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0231 |
| methylprednisolone | Methylprednisolone 8 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1349 |
| methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Proficient Rx LP | 82804-007 |
| methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1348 |
| methylprednisolone | Methylprednisolone 16 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1350 |
| methylprednisolone | Methylprednisolone 32 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1351 |
| methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | BluePoint Laboratories | 68001-624 |
| methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-916 |
| methylprednisolone | Methylprednisolone 8 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-917 |
| methylprednisolone | Methylprednisolone 16 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-918 |
| methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | A-S Medication Solutions | 50090-3811 |