Acetaminophen, Aspirin And Caffeine Tablet
NDC Package 71309-079-03

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

Package Information

Acetaminophen, Aspirin And Caffeine tablets is • do not use more than directed • adults: take 2 caplets with a glass of water • if symptoms persist or worsen, ask your doctor • do not take more than 2 caplets in 24 hours, unless directed by a doctor • under 18 years of age: ask a doctor. This formulation utilizes a tablet delivery system. Marketed by Safrel Pharmaceuticals, Llc., this product is identified by NDC 71309-079 and is authorized under FDA application ANDA214039.

Identification & Billing

NDC Package Code
71309-079-03
Package Description
300 TABLET in 1 BOTTLE
Product Code
71309-079
11-Digit Billing Format
71309007903
RxNorm Crosswalk
  • RxCUI: 308297 - acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet
  • RxCUI: 308297 - APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet

Clinical Specifications

Proprietary Name
Acetaminophen, Aspirin And Caffeine
Non-Proprietary Name
Acetaminophen, Aspirin And Caffeine
Substance Name
Acetaminophen; Aspirin; Caffeine
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)
Pharmacologic Class
Usage Information
• do not use more than directed • adults: take 2 caplets with a glass of water • if symptoms persist or worsen, ask your doctor • do not take more than 2 caplets in 24 hours, unless directed by a doctor • under 18 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Safrel Pharmaceuticals, Llc.
Product Type
Human Otc Drug
FDA Application #
ANDA214039
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-15-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71309-079-03 identifies a specific commercial package of 300 tablet in 1 bottle of Acetaminophen, Aspirin And Caffeine, a human over the counter drug labeled by Safrel Pharmaceuticals, Llc.. This tablet is formulated for oral use and contains acetaminophen; aspirin; caffeine 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 Safrel Pharmaceuticals, Llc. on April 15, 2021. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71309007903. 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)
71309-079-03
11-Digit CMS (5-4-2)
71309-0079-03

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