Prescription drug · ANDA
Methylprednisolone sodium succinate NDC 43598-128
Methylprednisolone sodium succinate 500 mg/8mL · Injection · Intramuscular, Intravenous · Dr. Reddy's Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-128-11 | 43598012811 | 1 VIAL, MULTI-DOSE in 1 CARTON (43598-128-11) / 8 mL in 1 VIAL, MULTI-DOSEMarketed from Mar 24, 2022 |
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 sodium succinate
- Generic name (nonproprietary)
- methylprednisolone sodium succinate
- Active ingredients
- Methylprednisolone sodium succinate — 500 mg/8mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Dr. Reddy's Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212396
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43598-128_9846244f-7189-5a82-a2aa-8f123805ee1fSPL ID 9846244f-7189-5a82-a2aa-8f123805ee1fSPL set ID 738753c7-507d-4881-5194-02dd7597768bRxCUI 311659, 314099, 1743704UNII LEC9GKY20KUPC 0343598128115, 0343598130743, 0343598127453, 0343598129013
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N443598012811followed by a unit qualifier and the quantityPackage 43598-0128-11. 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 When oral therapy is not feasible, and the strength, dosage form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of methylprednisolone sodium succinate for injection, USP is indicated as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases : Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema mult…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212396
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 sodium succinate | Methylprednisolone sodium succinate 125 mg/2mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-3684 |
| Methylprednisolone Sodium Succinatemethylprednisolone | Methylprednisolone sodium succinate 500 mg/8mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Tianjin Kingyork Pharmaceuticals Co., Ltd | 82094-403 |
| Methylprednisolone Sodium Succinatemethylprednisolone | Methylprednisolone sodium succinate 40 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Tianjin Kingyork Pharmaceuticals Co., Ltd | 82094-401 |
| Methylprednisolone Sodium Succinatemethylprednisolone | Methylprednisolone sodium succinate 125 mg/2mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Tianjin Kingyork Pharmaceuticals Co., Ltd | 82094-402 |
| Methylprednisolone Sodium Succinatemethylprednisolone | Methylprednisolone sodium succinate 1 g/16mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Tianjin Kingyork Pharmaceuticals Co., Ltd | 82094-404 |
| Methylprednisolone Sodium Succinatemethylprednisolone | Methylprednisolone sodium succinate 2 g/30.6mL | Injection, Powder, Lyophilized, For solutionIntramuscular, Intravenous | Tianjin Kingyork Pharmaceuticals Co., Ltd | 82094-405 |
| Methylprednisolone sodium succinate | Methylprednisolone sodium succinate 40 mg/mL | InjectionIntramuscular, Intravenous | Dr. Reddy's Laboratories Inc | 43598-127 |
| Methylprednisolone sodium succinate | Methylprednisolone sodium succinate 1 g/16mL | InjectionIntramuscular, Intravenous | Dr. Reddy's Laboratories Inc | 43598-130 |
| Methylprednisolone sodium succinate | Methylprednisolone sodium succinate 125 mg/2mL | InjectionIntramuscular, Intravenous | Dr. Reddy's Laboratories Inc | 43598-129 |
| Methylprednisolone Sodium Succinate | Methylprednisolone sodium succinate 125 mg/2mL | InjectionIntravascular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1695 |