Prescription drug · ANDA
MethylPREDNISolone NDC 55289-649
Methylprednisolone 4 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-649-30 | 55289064930 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-649-30)Marketed from Aug 12, 2016 |
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 — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 55289
- 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 55289-649_58b3135f-861b-52b7-e063-6294a90acb61SPL ID 58b3135f-861b-52b7-e063-6294a90acb61SPL set ID a14c4f76-6dd5-4c84-b6e5-e5abf19ab559RxCUI 259966UNII X4W7ZR7023UPC 0355289649304
- 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
N455289064930followed by a unit qualifier and the quantityPackage 55289-0649-30. 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.
About NDC 55289-649
- What is NDC 55289-649?
- 55289-649 is the product NDC for MethylPREDNISolone, Methylprednisolone 4 mg/1 tablet, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- MethylPREDNISolone.
- What is the active ingredient?
- Methylprednisolone.
- Who is the labeler?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 55289. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for MethylPREDNISolone?
- 47 other product NDCs are listed under this name. See all MethylPREDNISolone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other MethylPREDNISolone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | BluePoint Laboratories | 68001-624 | 68001-0624-01 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4213 | 70518-4213-00 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-961 | 60760-0961-21 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0230 | 80425-0230-01 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0231 | 80425-0231-01 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0255 | 80425-0255-01 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Direct_Rx | 72189-264 | 72189-0264-21 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7833 | 68788-7833-02 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2864 | 70518-2864-00 |
| Methylprednisolone | Methylprednisolone 32 mg/1 | TabletOral | Chartwell RX, LLC | 62135-763 | 62135-0763-26 |
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 | Bryant Ranch Prepack | 72162-1161 |
| Methylprednisolone | Methylprednisolone 4 mg/1 | TabletOral | American Health Packaging | 68084-149 |
| MethylPREDNISolone | Methylprednisolone 4 mg/1 | TabletOral | Par Health USA, LLC | 0603-4593 |
| MethylPREDNISolone | Methylprednisolone 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2218 |
| MethylPREDNISolone | Methylprednisolone 4 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2226 |