Mefloquine Hydrochloride Tablet
NDC Package 0555-0171-78

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

Package Information

Mefloquine Hydrochloride tablets is use of mefloquine hydrochloride tablets is contraindicated in patients with a known hypersensitivity to mefloquine or related compounds (e.g., quinine and quinidine) or to any of the excipients contained in the formulation. This formulation utilizes a tablet delivery system. Marketed by Teva Pharmaceuticals Usa, Inc., this product is identified by NDC 0555-0171 and is authorized under FDA application ANDA076392.

Identification & Billing

NDC Package Code
0555-0171-78
Package Description
25 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (0555-0171-88)
Product Code
0555-0171
11-Digit Billing Format
00555017178
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
25 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mefloquine Hydrochloride
Non-Proprietary Name
Mefloquine Hydrochloride
Substance Name
Mefloquine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MEFLOQUINE HYDROCHLORIDE 250 mg/1
Pharmacologic Class
Antimalarial - [EPC] (Established Pharmacologic Class)
Usage Information
Use of mefloquine hydrochloride tablets is contraindicated in patients with a known hypersensitivity to mefloquine or related compounds (e.g., quinine and quinidine) or to any of the excipients contained in the formulation. Mefloquine hydrochloride tablets should not be prescribed for prophylaxis in patients with active depression, a recent history of depression, generalized anxiety disorder, psychosis, schizophrenia or other major psychiatric disorders, or with a history of convulsions.

Regulatory & Marketing

Labeler Name
Teva Pharmaceuticals Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076392
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-06-2004
Listing Expiration
12-31-2027
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0555-0171-78 identifies a specific commercial package of 25 blister pack in 1 carton / 1 tablet in 1 blister pack (0555-0171-88) of Mefloquine Hydrochloride, a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. This tablet is formulated for oral use and contains mefloquine hydrochloride 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 Teva Pharmaceuticals Usa, Inc. on January 06, 2004. The current certification is valid through December 31, 2027.

How is this Teva Pharmaceuticals Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00555017178. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 25 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)
0555-0171-78
11-Digit CMS (5-4-2)
00555-0171-78

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