Methylprednisolone Acetate
NDC Package 0781-3522-75

11-digit billing NDC: 00781352275 · Billing unit: ML · 5 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Methylprednisolone Acetate is dEPO-MEDROL is contraindicated in patients with known hypersensitivity to the product and its constituents.Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.DEPO-MEDROL Sterile Aqueous Suspension is contraindicated for intrathecal administration. Marketed by Sandoz Inc., this product is identified by NDC 0781-3522 and is authorized under FDA application ANDA214870.

Identification & Billing

NDC Package Code
0781-3522-75
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE
Product Code
0781-3522
11-Digit Billing Format
00781352275
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML

Clinical Specifications

Proprietary Name
Methylprednisolone Acetate
Dosage Form
-
Usage Information
DEPO-MEDROL is contraindicated in patients with known hypersensitivity to the product and its constituents.Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.DEPO-MEDROL Sterile Aqueous Suspension is contraindicated for intrathecal administration. Reports of severe medical events have been associated with this route of administration. DEPO-MEDROL is contraindicated for use in premature infants because the formulation contains benzyl alcohol. (See WARNINGS and PRECAUTIONS: Pediatric Use.) DEPO-MEDROL is contraindicated in systemic fungal infections, except when administered as an intra-articular injection for localized joint conditions (see WARNINGS: Infections, Fungal Infections). MARCAINE is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death.MARCAINE is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide-type or to other components of MARCAINE solutions.

Regulatory & Marketing

Labeler Name
Sandoz Inc.
FDA Application #
ANDA214870
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-14-2024
Listing Expiration
12-31-2027
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1010
Source: ASP
Inj, methylpred acetate 1 mg
HCPCS Dosage 1 MG
Units / Pkg 200

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0781-3522). Click a package code to view its specific billing and regulatory data.

0781-3522-70
1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0781-3522-75 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose of Methylprednisolone Acetate, labeled by Sandoz Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sandoz Inc. on March 14, 2024. The current certification is valid through December 31, 2027.

How is this Sandoz Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781352275. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0781-3522-75
11-Digit CMS (5-4-2)
00781-3522-75

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.