Adult Low Dose
NDC Package 71309-003-05

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

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

Adult Low Dose is drink a full glass of water with each doseadults and children 12 years and over: take 4 to 8 tablets every 4 hours; not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor. Marketed by Safrel Pharmaceuticals, Llc., this product is identified by NDC 71309-003 and is authorized under FDA application part343.

Identification & Billing

NDC Package Code
71309-003-05
Package Description
500 BOTTLE in 1 BOTTLE / 1000 BOTTLE in 1 BOTTLE (71309-003-01) / 365 BOTTLE in 1 BOTTLE (71309-003-65) / 30 CARTON in 1 BOTTLE (71309-003-30) / 1 TABLET, DELAYED RELEASE in 1 CARTON
Product Code
71309-003
11-Digit Billing Format
71309000305
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Adult Low Dose
Dosage Form
-
Usage Information
Drink a full glass of water with each doseadults and children 12 years and over: take 4 to 8 tablets every 4 hours; not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor

Regulatory & Marketing

Labeler Name
Safrel Pharmaceuticals, Llc.
FDA Application #
part343
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-09-2016
Listing Expiration
12-31-2024
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 (71309-003). Click a package code to view its specific billing and regulatory data.

71309-003-02
2 POUCH in 1 POUCH / 2 TABLET, DELAYED RELEASE in 1 POUCH
71309-003-10
1000 TABLET, DELAYED RELEASE in 1 BOTTLE
71309-003-25
25 POUCH in 1 BOX / 2 TABLET, DELAYED RELEASE in 1 POUCH
71309-003-50
50 POUCH in 1 BOX / 2 TABLET, DELAYED RELEASE in 1 POUCH
71309-003-60
1 BOTTLE in 1 CARTON / 60 TABLET, DELAYED RELEASE in 1 BOTTLE

* 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 71309-003-05 identifies a specific commercial package of 500 bottle in 1 bottle / 1000 bottle in 1 bottle (71309-003-01) / 365 bottle in 1 bottle (71309-003-65) / 30 carton in 1 bottle (71309-003-30) / 1 tablet, delayed release in 1 carton of Adult Low Dose, labeled by Safrel Pharmaceuticals, Llc.. 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 Safrel Pharmaceuticals, Llc. on February 09, 2016. The current certification is valid through December 31, 2024.

How is this Safrel Pharmaceuticals, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71309000305. 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)
71309-003-05
11-Digit CMS (5-4-2)
71309-0003-05

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