NDC codes

FDA NDC Directory
Product NDC (as listed)65145-192Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65145-0192Add 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 NDC11-digit (billing)PackageCopy
65145-192-256514501922525 VIAL, SINGLE-DOSE in 1 CARTON (65145-192-25) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-192-01)Marketed from Feb 6, 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, Soft tissue
Labeler
Caplin Steriles LimitedNDC labeler code 65145
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 220556
Marketing start
Listing expires
Other FDA classes
Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers
Product ID 65145-192_23f98766-7571-49cb-8c1a-58fabba53965SPL ID 23f98766-7571-49cb-8c1a-58fabba53965SPL set ID 23f98766-7571-49cb-8c1a-58fabba53965RxCUI 1743779, 1743855UNII 43502P7F0PUPC 0365145192011, 0365145192257, 0365145193018, 0365145193254
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

N465145019225 followed by a unit qualifier and the quantity

Package 65145-0192-25. 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.

Full label on DailyMed (opens in a new tab)

About NDC 65145-192

What is NDC 65145-192?
65145-192 is the product NDC for Methylprednisolone Acetate, Methylprednisolone acetate 40 mg/mL injection, suspension, listed with the FDA by Caplin Steriles Limited. It has 1 package NDC, 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?
Caplin Steriles Limited, NDC labeler code 65145. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Methylprednisolone Acetate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Methylprednisolone AcetateMethylprednisolone acetate 80 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissueCaplin Steriles Limited65145-19365145-0193-25
Methylprednisolone acetateMethylprednisolone acetate 40 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissueAmneal Pharmaceuticals LLC70121-160970121-1609-0170121-1609-05
Methylprednisolone acetateMethylprednisolone acetate 80 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissueAmneal Pharmaceuticals LLC70121-161070121-1610-0170121-1610-05
Methylprednisolone AcetateMethylprednisolone acetate 40 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissueEugia US LLC55150-31355150-0313-0155150-0313-25
Methylprednisolone AcetateMethylprednisolone acetate 80 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissueEugia US LLC55150-31455150-0314-0155150-0314-25
Methylprednisolone acetateMethylprednisolone acetate 40 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissueAmneal Pharmaceuticals NY LLC60219-157360219-1573-0160219-1573-05
Methylprednisolone acetateMethylprednisolone acetate 80 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissueAmneal Pharmaceuticals NY LLC60219-157460219-1574-0160219-1574-05
methylprednisolone acetateMethylprednisolone acetate 40 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissueSagent Pharmaceuticals25021-82025021-0820-0525021-0820-10
methylprednisolone acetateMethylprednisolone acetate 80 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissueSagent Pharmaceuticals25021-82125021-0821-05
methylprednisolone acetateMethylprednisolone acetate 40 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Intrasynovial, Soft tissueSportpharm LLC85766-19585766-0195-05

All 17 Methylprednisolone Acetate NDCs

Other NDCs under ANDA 220556

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

FDA NDC Directory listings under ANDA 220556
ProductStrengthForm · routeLabelerProduct NDC
Methylprednisolone AcetateMethylprednisolone acetate 80 mg/mLInjection, SuspensionIntra-articular, Intralesional, Intramuscular, Soft tissueCaplin Steriles Limited65145-193

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in
Methylprednisolone Acetate NDC 65145-192 | Med-Code