Prescription drug · ANDA
Methylprednisolone Acetate NDC 55150-313
Methylprednisolone acetate 40 mg/mL · Injection, Suspension · Intra-articular, Intralesional, Intramuscular, Soft tissue · Eugia US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55150-313-01 | 55150031301 | 1 VIAL, MULTI-DOSE in 1 CARTON (55150-313-01) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 13, 2023 | |
| 55150-313-25 | 55150031325 | 25 VIAL, MULTI-DOSE in 1 CARTON (55150-313-25) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Apr 13, 2023 |
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 Acetate
- Generic name (nonproprietary)
- methylprednisolone acetate
- Active ingredients
- Methylprednisolone acetate — 40 mg/mL
- Dosage form
- Injection, Suspension
- Route
- Intra-articular, Intralesional, Intramuscular, Soft tissue
- Labeler
- Eugia US LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211930
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 55150-313_25c5133c-ee17-4be0-88a3-d0231e38f5a0SPL ID 25c5133c-ee17-4be0-88a3-d0231e38f5a0SPL set ID a0cbcdb5-f657-49f7-8f86-cc5959d69db0RxCUI 1358610, 1358617UNII 43502P7F0PUPC 0355150313013, 0355150314010
- 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
N455150031301followed by a unit qualifier and the quantityPackage 55150-0313-01. 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 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 erythroderma, mycosis fungoides, pemphigus, seve…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211930
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 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Eugia US LLC | 55150-314 |