Acetaminophen Tablet, Film Coated, Extended Release
NDC Package 11822-5019-2
Package Information
Acetaminophen tablets is a medication used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Rite Aid, this product is identified by NDC 11822-5019 and is authorized under FDA application ANDA211544.
Identification & Billing
- RxCUI: 1148399 - acetaminophen 650 MG 8HR Extended Release Oral Tablet
- RxCUI: 1148399 - 8 HR acetaminophen 650 MG Extended Release Oral Tablet
- RxCUI: 1148399 - 8 HR APAP 650 MG Extended Release Oral Tablet
- RxCUI: 1148399 - acetaminophen 650 MG 8 HR Extended Release Oral Tablet
Clinical Specifications
- Oral - Administration to or by way of the mouth.
- Oral - Administration to or by way of the mouth.
Regulatory & Marketing
Hierarchy Structure
- 11822 - Rite Aid
- 11822-5019 - Acetaminophen
- 11822-5019-2 - 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
- 11822-5019 - Acetaminophen
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 (11822-5019). Click a package code to view its specific billing and regulatory data.
* 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 11822-5019-2 identifies a specific commercial package of 100 tablet, film coated, extended release in 1 bottle of Acetaminophen, a human over the counter drug labeled by Rite Aid. This tablet, film coated, extended release is formulated for oral use and contains acetaminophen 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 Rite Aid on November 01, 2024. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
How is this Rite Aid product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 11822501902. 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:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.