Prescription drug · ANDA
methylprednisolone acetate NDC 68083-616
Methylprednisolone acetate 40 mg/mL · Injection, Suspension · Intralesional, Intramuscular, Intrasynovial, Soft tissue · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-616-01 | 6808306160168083061601 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-616-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 2, 2026 | |
| 68083-616-25 | 6808306162568083061625 | 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-616-25) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 2, 2026 |
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
- Intralesional, Intramuscular, Intrasynovial, Soft tissue
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219662
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68083-616_c5f61720-6b57-4514-b833-24ce74c1074cSPL ID c5f61720-6b57-4514-b833-24ce74c1074cSPL set ID 04a15892-79e5-4e00-8a7d-21d3242cefcaRxCUI 1743779, 1743855UNII 43502P7F0PUPC 0368083616250, 0368083617257, 0368083617011, 0368083616014
- 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
N468083061601followed by a unit qualifier and the quantityPackage 68083-0616-01. 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 dermatitis, mycosis fungoides, pemphigus, severe…
Excerpt only. Read the full label for complete information.
About NDC 68083-616
- What is NDC 68083-616?
- 68083-616 is the product NDC for methylprednisolone acetate, Methylprednisolone acetate 40 mg/mL injection, suspension, listed with the FDA by Gland Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- methylprednisolone acetate.
- What is the active ingredient?
- Methylprednisolone acetate.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. 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 acetate?
- 16 other product NDCs are listed under this name. See all methylprednisolone acetate NDCs.
- Is there a related HCPCS / J-code?
- Yes: J1040, Injection, methylprednisolone acetate, 80 mg. See Billing references above.
Related NDCs: other methylprednisolone acetate 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 Acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Caplin Steriles Limited | 65145-192 | 65145-0192-25 |
| Methylprednisolone Acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Caplin Steriles Limited | 65145-193 | 65145-0193-25 |
| Methylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue | Amneal Pharmaceuticals LLC | 70121-1609 | 70121-1609-0170121-1609-05 |
| Methylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue | Amneal Pharmaceuticals LLC | 70121-1610 | 70121-1610-0170121-1610-05 |
| Methylprednisolone Acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Eugia US LLC | 55150-313 | 55150-0313-0155150-0313-25 |
| Methylprednisolone Acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Eugia US LLC | 55150-314 | 55150-0314-0155150-0314-25 |
| Methylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue | Amneal Pharmaceuticals NY LLC | 60219-1573 | 60219-1573-0160219-1573-05 |
| Methylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissue | Amneal Pharmaceuticals NY LLC | 60219-1574 | 60219-1574-0160219-1574-05 |
| methylprednisolone acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue | Sagent Pharmaceuticals | 25021-820 | 25021-0820-0525021-0820-10 |
| methylprednisolone acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue | Sagent Pharmaceuticals | 25021-821 | 25021-0821-05 |
Other NDCs under ANDA 219662
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, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Gland Pharma Limited | 68083-617 |
| Methylprednisolone Acetate | Methylprednisolone acetate 80 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Gland Pharma Limited | 68083-622 |
| Methylprednisolone Acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Gland Pharma Limited | 68083-620 |
| Methylprednisolone Acetate | Methylprednisolone acetate 40 mg/mL | Injection, SuspensionIntralesional, Intramuscular, Intrasynovial, Soft tissue | Gland Pharma Limited | 68083-621 |