Primatene Tablet
NDC Package 80070-600-60

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

Primatene (ephedrine hydrochloride) tablets is do not take more than directedadults and children 12 years and over: take 1-2 tablets every 4 hours as needed. This formulation utilizes a tablet delivery system. Marketed by Foundation Consumer Brands, this product is identified by NDC 80070-600 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
80070-600-60
Package Description
5 BLISTER PACK in 1 CARTON / 12 TABLET in 1 BLISTER PACK
Product Code
80070-600
11-Digit Billing Format
80070060060
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Primatene
Non-Proprietary Name
Ephedrine Hydrochloride
Substance Name
Ephedrine 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)
EPHEDRINE HYDROCHLORIDE 12.5 mg/1
Pharmacologic Class
Usage Information
Do not take more than directedadults and children 12 years and over: take 1-2 tablets every 4 hours as needed. Do not take more than 12 tablets in 24 hours.children under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
Foundation Consumer Brands
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-22-2021
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 (80070-600). Click a package code to view its specific billing and regulatory data.

80070-600-24
2 BLISTER PACK in 1 CARTON / 12 TABLET 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 80070-600-60 identifies a specific commercial package of 5 blister pack in 1 carton / 12 tablet in 1 blister pack of Primatene, a human over the counter drug labeled by Foundation Consumer Brands. This tablet is formulated for oral use and contains ephedrine 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 Foundation Consumer Brands on January 22, 2021. The current certification is valid through December 31, 2026.

How is this Foundation Consumer Brands product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80070060060. 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 (5-3-2)
80070-600-60
11-Digit CMS (5-4-2)
80070-0600-60

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