Zephrex D Capsule, Gelatin Coated
NDC Package 0113-0401-67

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

Package Information

Zephrex D (pseudoephedrine hydrochloride) capsules is adults and children 12 years and over•take 2 softgels every 4 to 6 hours•do not take more than 8 softgels in 24 hourschildren ages 6 to under 12 years•take 1 softgel every 4 to 6 hours•do not take more than 4 softgels in 24 hourschildren under 6 yearsdo not use this product in children under 6 years of age. This formulation utilizes a capsule, gelatin coated delivery system. Marketed by L. Perrigo Company, this product is identified by NDC 0113-0401 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0113-0401-67
Package Description
48 BLISTER PACK in 1 CARTON / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Product Code
0113-0401
11-Digit Billing Format
00113040167
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zephrex D
Non-Proprietary Name
Pseudoephedrine Hydrochloride
Substance Name
Pseudoephedrine Hydrochloride
Dosage Form
Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg/1
Pharmacologic Class
Usage Information
Adults and children 12 years and over•take 2 softgels every 4 to 6 hours•do not take more than 8 softgels in 24 hourschildren ages 6 to under 12 years•take 1 softgel every 4 to 6 hours•do not take more than 4 softgels in 24 hourschildren under 6 yearsdo not use this product in children under 6 years of age

Regulatory & Marketing

Labeler Name
L. Perrigo Company
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-04-2016
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0113-0401). Click a package code to view its specific billing and regulatory data.

0113-0401-62
24 BLISTER PACK in 1 CARTON / 1 CAPSULE, GELATIN COATED 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 0113-0401-67 identifies a specific commercial package of 48 blister pack in 1 carton / 1 capsule, gelatin coated in 1 blister pack of Zephrex D, a human over the counter drug labeled by L. Perrigo Company. This capsule, gelatin coated is formulated for oral use and contains pseudoephedrine 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 L. Perrigo Company on November 04, 2016. The current certification is valid through December 31, 2026.

How is this L. Perrigo Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00113040167. 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)
0113-0401-67
11-Digit CMS (5-4-2)
00113-0401-67

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