Prescription drug · ANDA
Methylprednisolone acetate NDC 50090-5894
Methylprednisolone acetate 40 mg/mL · Injection, Suspension · Intra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5894-0 | 50090589400 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50090-5894-0) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 12, 2022 |
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 acetate
- Generic name (nonproprietary)
- methylprednisolone acetate
- Active ingredients
- Methylprednisolone acetate — 40 mg/mL
- Dosage form
- Injection, Suspension
- Route
- Intra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210043
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 50090-5894_40739c05-2fb7-4641-a618-9fa5b940480dSPL ID 40739c05-2fb7-4641-a618-9fa5b940480dSPL set ID 1084208f-3b86-4aef-8247-5b6ed6cd50c7RxCUI 1743779UNII 43502P7F0P
- 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 codeMed-Code curated
J1040 — Injection, methylprednisolone acetate, 80 mg
Billing unit: 80 mg. Units on the claim = dose given ÷ 80 mg.
J1040 applies to methylprednisolone acetate. Methylprednisolone sodium succinate (for IV use) has different codes.
- 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
N450090589400followed by a unit qualifier and the quantityPackage 50090-5894-00. 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 A. For Intramuscular Administration 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 intramuscular use of methylprednisolone acetate injectable suspension 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 dermatitis, mycosis fungoides, pemphigus, severe e…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210043
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 acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue | Sportpharm LLC | 85766-031 |
| Methylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | A-S Medication Solutions | 50090-6024 |
| Methylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue | Amneal Pharmaceuticals NY LLC | 60219-1573 |
| Methylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Amneal Pharmaceuticals NY LLC | 60219-1574 |
| Methylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Amneal Pharmaceuticals LLC | 70121-1552 |
| Methylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue | Amneal Pharmaceuticals LLC | 70121-1573 |
| Methylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Amneal Pharmaceuticals LLC | 70121-1574 |