Hydrocodone Bitartrate Tablet, Extended Release
NDC Package 47781-397-60

11-digit billing NDC: 47781039760 · Billing unit: EA · 60 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hydrocodone Bitartrate tablets is hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including hydrocodone bitartrate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Hydrocodone bitartrate extended-release tablets are not indicated as an as-needed (prn) analgesic. This formulation utilizes a tablet, extended release delivery system. Marketed by Alvogen Inc., this product is identified by NDC 47781-397 and is authorized under FDA application ANDA208269.

Identification & Billing

NDC Package Code
47781-397-60
Package Description
60 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
47781-397
11-Digit Billing Format
47781039760
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
  • RxCUI: 1595730 - HYDROcodone bitartrate 20 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent
  • RxCUI: 1595730 - Abuse-Deterrent 24 HR hydrocodone bitartrate 20 MG Extended Release Oral Tablet
  • RxCUI: 1595730 - hydrocodone bitartrate 20 MG 24 HR Extended Release Oral Tablet, Abuse-Deterrent
  • RxCUI: 1595740 - HYDROcodone bitartrate 30 MG 24HR Extended Release Oral Tablet, Abuse-Deterrent
  • RxCUI: 1595740 - Abuse-Deterrent 24 HR hydrocodone bitartrate 30 MG Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Hydrocodone Bitartrate
Non-Proprietary Name
Hydrocodone Bitartrate
Substance Name
Hydrocodone Bitartrate
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROCODONE BITARTRATE 100 mg/1
Pharmacologic Class
Usage Information
Hydrocodone bitartrate extended-release tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.Limitations of UseBecause of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including hydrocodone bitartrate extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.Hydrocodone bitartrate extended-release tablets are not indicated as an as-needed (prn) analgesic.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Alvogen Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208269
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-03-2021
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 47781-397-60 identifies a specific commercial package of 60 tablet, extended release in 1 bottle of Hydrocodone Bitartrate, a human prescription drug labeled by Alvogen Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, extended release is formulated for oral use and contains 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 Alvogen Inc. on March 03, 2021. The current certification is valid through December 31, 2027.

How is this Alvogen Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 47781039760. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
47781-397-60
11-Digit CMS (5-4-2)
47781-0397-60

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