Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
NDC Package 42195-840-10

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

Package Information

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

Acetaminophen, Caffeine, Dihydrocodeine Bitartrate is acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules are indicated for the relief of moderate to moderately severe pain. Marketed by Xspire Pharma, Llc, this product is identified by NDC 42195-840 and is authorized under FDA application ANDA204785.

Identification & Billing

NDC Package Code
42195-840-10
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
42195-840
11-Digit Billing Format
42195084010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 1596108 - acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule
  • RxCUI: 1596108 - APAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule

Clinical Specifications

Proprietary Name
Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
Dosage Form
-
Usage Information
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules are indicated for the relief of moderate to moderately severe pain.

Regulatory & Marketing

Labeler Name
Xspire Pharma, Llc
FDA Application #
ANDA204785
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-05-2015
Listing Expiration
12-31-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 42195-840-10 identifies a specific commercial package of 100 capsule in 1 bottle of Acetaminophen, Caffeine, Dihydrocodeine Bitartrate, labeled by Xspire Pharma, 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 Xspire Pharma, Llc on August 05, 2015. The current certification is valid through December 31, 2023.

How is this Xspire Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42195084010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
42195-840-10
11-Digit CMS (5-4-2)
42195-0840-10

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