Extra Strength Acetaminophen Pm Tablet
NDC Package 49483-430-40

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

Package Information

Extra Strength Acetaminophen Pm (acetaminophen 500mg/ diphenhydramine hcl 25mg) tablets is usestemporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness. This formulation utilizes a tablet delivery system. Marketed by Time Cap Labs Inc, this product is identified by NDC 49483-430 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
49483-430-40
Package Description
400 TABLET in 1 BOTTLE
Product Code
49483-430
11-Digit Billing Format
49483043040
RxNorm Crosswalk
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet
  • RxCUI: 1092189 - acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet
  • RxCUI: 1092189 - APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet

Clinical Specifications

Proprietary Name
Extra Strength Acetaminophen Pm
Non-Proprietary Name
Acetaminophen 500mg/ Diphenhydramine Hcl 25mg
Substance Name
Acetaminophen; Diphenhydramine 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)
Pharmacologic Class
Usage Information
Usestemporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Regulatory & Marketing

Labeler Name
Time Cap Labs Inc
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-22-2023
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 49483-430-40 identifies a specific commercial package of 400 tablet in 1 bottle of Extra Strength Acetaminophen Pm, a human over the counter drug labeled by Time Cap Labs Inc. This tablet is formulated for oral use and contains acetaminophen; diphenhydramine 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 Time Cap Labs Inc on July 22, 2023. The current certification is valid through December 31, 2026.

How is this Time Cap Labs Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49483043040. 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)
49483-430-40
11-Digit CMS (5-4-2)
49483-0430-40

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