Prescription drug · NDA
Depo-Medrol (Methylprednisolone acetate) NDC 76420-081
Methylprednisolone acetate 80 mg/mL · Injection, Suspension · Intra-articular, Intralesional, Intramuscular, Soft tissue · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-081-01 | 76420008101 | 1 mL in 1 VIAL, SINGLE-DOSE (76420-081-01)Marketed from Apr 9, 2020 |
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)
- Depo-Medrol
- Generic name (nonproprietary)
- methylprednisolone acetate
- Active ingredients
- Methylprednisolone acetate — 80 mg/mL
- Dosage form
- Injection, Suspension
- Route
- Intra-articular, Intralesional, Intramuscular, Soft tissue
- Labeler
- Asclemed USA, Inc.NDC labeler code 76420
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 011757
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 76420-081_ead30b86-564f-7e78-e053-2a95a90ab41cSPL ID ead30b86-564f-7e78-e053-2a95a90ab41cSPL set ID cb0e1c92-d2df-47f8-ab3f-edc1a98bf4b6RxCUI 1743855, 1743856UNII 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.
- 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
N476420008101followed by a unit qualifier and the quantityPackage 76420-0081-01. 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 DEPO-MEDROL Sterile Aqueous 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, seasonal or perennial allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases : Bullous dermatitis herpetiformis, exfoliative dermatitis, mycos…
Excerpt only. Read the full label for complete information.
About NDC 76420-081
- What is NDC 76420-081?
- 76420-081 is the product NDC for Depo-Medrol (methylprednisolone acetate), Methylprednisolone acetate 80 mg/mL injection, suspension, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Depo-Medrol (Methylprednisolone acetate).
- What is the active ingredient?
- Methylprednisolone acetate.
- Who is the labeler?
- Asclemed USA, Inc., NDC labeler code 76420. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Depo-Medrol?
- 9 other product NDCs are listed under this name. See all Depo-Medrol NDCs.
- Is there a related HCPCS / J-code?
- Yes: J1040, Injection, methylprednisolone acetate, 80 mg. See Billing references above.
Related NDCs: other Depo-Medrol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 20 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Pharmacia & Upjohn Company LLC | 0009-0274 | 00009-0274-01 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Pharmacia & Upjohn Company LLC | 0009-0280 | 00009-0280-0200009-0280-0300009-0280-51+1 more |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Pharmacia & Upjohn Company LLC | 0009-0306 | 00009-0306-0200009-0306-12 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Pharmacia & Upjohn Company LLC | 0009-3073 | 00009-3073-2200009-3073-23 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Pharmacia & Upjohn Company LLC | 0009-3475 | 00009-3475-0100009-3475-03 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | A-S Medication Solutions | 50090-0436 | 50090-0436-00 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | A-S Medication Solutions | 50090-0556 | 50090-0556-00 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | A-S Medication Solutions | 50090-1823 | 50090-1823-00 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | A-S Medication Solutions | 50090-2098 | 50090-2098-00 |
Other NDCs under NDA 011757
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 |
|---|---|---|---|---|
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 20 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Pharmacia & Upjohn Company LLC | 0009-0274 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Pharmacia & Upjohn Company LLC | 0009-0280 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Pharmacia & Upjohn Company LLC | 0009-0306 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Pharmacia & Upjohn Company LLC | 0009-3073 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Pharmacia & Upjohn Company LLC | 0009-3475 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | A-S Medication Solutions | 50090-0436 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | A-S Medication Solutions | 50090-0556 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | A-S Medication Solutions | 50090-1823 |
| Depo-Medrolmethylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | A-S Medication Solutions | 50090-2098 |