methylprednisolone acetate NDC 85766-195

NDC codes

FDA NDC Directory

Product NDC (as listed)85766-195Labeler and product segments. Claims need a package NDC.

Product NDC at billing width85766-0195Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
85766-195-05	85766019505	1 VIAL in 1 CARTON (85766-195-05) / 5 mL in 1 VIALMarketed from Apr 1, 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: Intra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue
Labeler: Sportpharm LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201835
Marketing start: Nov 15, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 85766-195_4e657577-390a-d946-e063-6294a90ab553SPL ID 4e657577-390a-d946-e063-6294a90ab553SPL set ID 904b098c-9068-42ed-958f-6ab78ea42b1fRxCUI 1358610UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N485766019505 followed by a unit qualifier and the quantity

Package 85766-0195-05. 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 Apr 1, 2026.

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, 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, serum sickness, transfusion reactions. Dermatologic Diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201835

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 201835
Product	Strength	Form · route	Labeler	Product NDC
methylprednisolone acetate	Methylprednisolone acetate 40 mg/mL	Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue	Sagent Pharmaceuticals	25021-820
methylprednisolone acetate	Methylprednisolone acetate 80 mg/mL	Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue	Sagent Pharmaceuticals	25021-821