Aspirin Tablet, Delayed Release
NDC Package 77333-035-20

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

Package Information

Aspirin tablets is aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as muscle aches, toothaches, common cold, and headaches. This formulation utilizes a tablet, delayed release delivery system. Marketed by Gendose Pharmaceuticals, Llc, this product is identified by NDC 77333-035 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
77333-035-20
Package Description
150 BLISTER PACK in 1 BOX / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (77333-035-25)
Product Code
77333-035
11-Digit Billing Format
77333003520
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Aspirin Enteric Coated, Regular Strength
Non-Proprietary Name
Aspirin
Substance Name
Aspirin
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ASPIRIN 325 mg/1
Pharmacologic Class
Usage Information
Aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as muscle aches, toothaches, common cold, and headaches. It may also be used to reduce pain and swelling in conditions such as arthritis. Aspirin is known as a salicylate and a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a certain natural substance in your body to reduce pain and swelling. Consult your doctor before treating a child younger than 12 years. Your doctor may direct you to take a low dose of aspirin to prevent blood clots. This effect reduces the risk of stroke and heart attack. If you have recently had surgery on clogged arteries (such as bypass surgery, carotid endarterectomy, coronary stent), your doctor may direct you to use aspirin in low doses as a "blood thinner" to prevent blood clots.

Regulatory & Marketing

Labeler Name
Gendose Pharmaceuticals, Llc
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-15-2026
Listing Expiration
12-31-2027
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 77333-035-20 identifies a specific commercial package of 150 blister pack in 1 box / 1 tablet, delayed release in 1 blister pack (77333-035-25) of Aspirin Enteric Coated, Regular Strength, a human over the counter drug labeled by Gendose Pharmaceuticals, Llc. This tablet, delayed release is formulated for oral use and contains aspirin 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 Gendose Pharmaceuticals, Llc on May 15, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as muscle aches, toothaches, common cold, and headaches. It may also be used to reduce pain and swelling in conditions such as arthritis. Aspirin is known as a salicylate and a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a certain natural substance in your body to reduce pain and swelling. Consult your doctor before treating a child younger than 12 years. Your doctor may direct you to take a low dose of aspirin to prevent blood clots. This effect reduces the risk of stroke and heart attack. If you have recently had surgery on clogged arteries (such as bypass surgery, carotid endarterectomy, coronary stent), your doctor may direct you to use aspirin in low doses as a "blood thinner" to prevent blood clots.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 77333003520. 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)
77333-035-20
11-Digit CMS (5-4-2)
77333-0035-20

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