methylprednisolone acetate NDC 25021-821

NDC codes

FDA NDC Directory

Product NDC (as listed)25021-821Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25021-0821Add 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
25021-821-05	25021082105	1 VIAL in 1 CARTON (25021-821-05) / 5 mL in 1 VIALMarketed from Nov 15, 2021

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 — 80 mg/mL
Dosage form: Injection, Suspension
Route: Intra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue
Labeler: Sagent Pharmaceuticals
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 25021-821_f73618f0-0723-4d8b-8a8d-b9081acb44f9SPL ID f73618f0-0723-4d8b-8a8d-b9081acb44f9SPL set ID f98314ea-a4e4-4f78-987b-3e9b45a08bb4RxCUI 1358610, 1358617UNII 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

N425021082105 followed by a unit qualifier and the quantity

Package 25021-0821-05. 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 Mar 2, 2025.

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 40 mg/mL	Injection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissue	Sportpharm LLC	85766-195