Hydrocodone Bitartrate And Acetaminophen Tablet
NDC Package 63304-497-01

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

Package Information

Hydrocodone Bitartrate And Acetaminophen tablets is uSP are indicated for the management of moderate to moderately severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):•have not been tolerated, or are not expected to be tolerated,•have not provided adequate analgesia, or are not expected to provide adequate analgesia. This formulation utilizes a tablet delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 63304-497 and is authorized under FDA application ANDA040826.

Identification & Billing

NDC Package Code
63304-497-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
63304-497
11-Digit Billing Format
63304049701
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: 856999 - HYDROcodone bitartrate 10 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 856999 - acetaminophen 325 MG / hydrocodone bitartrate 10 MG Oral Tablet
  • RxCUI: 856999 - APAP 325 MG / hydrocodone bitartrate 10 MG Oral Tablet

Clinical Specifications

Proprietary Name
Hydrocodone Bitartrate And Acetaminophen
Non-Proprietary Name
Hydrocodone Bitartrate And Acetaminophen
Substance Name
Acetaminophen; Hydrocodone Bitartrate
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
Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of moderate to moderately severe pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):•have not been tolerated, or are not expected to be tolerated,•have not provided adequate analgesia, or are not expected to provide adequate analgesia
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040826
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-31-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63304-497). Click a package code to view its specific billing and regulatory data.

63304-497-03
10 TABLET in 1 BOTTLE
63304-497-05
500 TABLET in 1 BOTTLE
63304-497-10
1000 TABLET in 1 BOTTLE
63304-497-69
10 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (63304-497-11)

* 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 63304-497-01 identifies a specific commercial package of 100 tablet in 1 bottle of Hydrocodone Bitartrate And Acetaminophen, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains acetaminophen; hydrocodone bitartrate 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 Sun Pharmaceutical Industries, Inc. on July 31, 2018. The current certification is valid through December 31, 2026.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63304049701. 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)
63304-497-01
11-Digit CMS (5-4-2)
63304-0497-01

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