Methylprednisolone Sodium Succinate Injection, Powder, For Solution
NDC Package 0143-9182-01
Package Information
Methylprednisolone Sodium Succinate injection is 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 intravenous or intramuscular use of Methylprednisolone Sodium Succinate for Injection, USP, is indicated as follows:. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0143-9182 and is authorized under FDA application ANDA202691.
Identification & Billing
- RxCUI: 314099 - methylPREDNISolone 62.5 MG/ML Injectable Solution
- RxCUI: 314099 - methylprednisolone 62.5 MG/ML Injectable Solution
- RxCUI: 314099 - methylprednisolone (as methylprednisolone sodium succinate) 62.5 MG/ML Injectable Solution
Clinical Specifications
- Intramuscular - Administration within a muscle.
- Intravenous - Administration within or into a vein or veins.
Regulatory & Marketing
Hierarchy Structure
- 0143 - Hikma Pharmaceuticals Usa Inc.
- 0143-9182 - Methylprednisolone Sodium Succinate
- 0143-9182-01 - 1 VIAL, MULTI-DOSE in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE
- 0143-9182 - Methylprednisolone Sodium Succinate
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0143-9182-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 1 injection, powder, for solution in 1 vial, multi-dose of Methylprednisolone Sodium Succinate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This injection, powder, for solution is formulated for intramuscular; intravenous use and contains methylprednisolone sodium succinate as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Hikma Pharmaceuticals Usa Inc. on January 15, 2024. The current certification is valid through December 31, 2026.
How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00143918201. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.