Meperidine Hydrochloride
NDC Package 0054-4595-25

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Meperidine Hydrochloride is tablets and Oral Solution is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Meperidine Hydrochloride Tablets and Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:•Have not been tolerated, or are not expected to be tolerated,•Have not provided adequate analgesia, or are not expected to provide adequate analgesia.Meperidine Hydrochloride Tablets or Oral Solution should not be used for treatment of chronic pain. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-4595 and is authorized under FDA application ANDA040110.

Identification & Billing

NDC Package Code
0054-4595-25
Package Description
100 TABLET in 1 BOTTLE
Product Code
0054-4595
11-Digit Billing Format
00054459525
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Meperidine Hydrochloride
Dosage Form
-
Usage Information
Meperidine Hydrochloride Tablets and Oral Solution is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.2)], reserve Meperidine Hydrochloride Tablets and Oral Solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:•Have not been tolerated, or are not expected to be tolerated,•Have not provided adequate analgesia, or are not expected to provide adequate analgesia.Meperidine Hydrochloride Tablets or Oral Solution should not be used for treatment of chronic pain. Prolonged meperidine use may increase the risk of toxicity (e.g. seizures) from the accumulation of the meperidine metabolite, normeperidine.

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
FDA Application #
ANDA040110
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-12-1997
End Marketing Date
08-23-2021
Listing Expiration
08-23-2021
Exclude Flag
D
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0054-4595-25 identifies a specific commercial package of 100 tablet in 1 bottle of Meperidine Hydrochloride, labeled by Hikma Pharmaceuticals Usa 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 Hikma Pharmaceuticals Usa Inc. on March 12, 1997. The current certification is valid through August 23, 2021.

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: 00054459525. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
0054-4595-25
11-Digit CMS (5-4-2)
00054-4595-25

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