Maxalt-mlt
NDC Package 54868-4499-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

Maxalt-mlt is mAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.Limitations of UseMAXALT should only be used where a clear diagnosis of migraine has been established. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4499 and is authorized under FDA application NDA020865.

Identification & Billing

NDC Package Code
54868-4499-2
Package Description
6 POUCH in 1 CONTAINER / 1 BLISTER PACK in 1 POUCH / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
11-Digit Billing Format
54868449902
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Maxalt-mlt
Dosage Form
-
Usage Information
MAXALT® and MAXALT-MLT® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old.Limitations of UseMAXALT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks.MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)].MAXALT is not indicated for the prevention of migraine attacks.Safety and effectiveness of MAXALT have not been established for cluster headache.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA020865
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-29-2009
Listing Expiration
12-31-2017
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-4499). Click a package code to view its specific billing and regulatory data.

3 POUCH in 1 CONTAINER / 1 BLISTER PACK in 1 POUCH / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
4 CONTAINER in 1 CARTON / 3 POUCH in 1 CONTAINER / 1 BLISTER PACK in 1 POUCH / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

* 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 54868-4499-2 identifies a specific commercial package of 6 pouch in 1 container / 1 blister pack in 1 pouch / 1 tablet, orally disintegrating in 1 blister pack of Maxalt-mlt, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 6 billable units per package. 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 Physicians Total Care, Inc. on December 29, 2009. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868449902. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 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 (5-4-1)
54868-4499-2
11-Digit CMS (5-4-2)
54868-4499-02

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