NDC Package 0115-1316-08 Oxymorphone Hydrochloride

Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0115-1316-08
Package Description:
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Oxymorphone Hydrochloride
Non-Proprietary Name:
Oxymorphone Hydrochloride
Substance Name:
Oxymorphone Hydrochloride
Usage Information:
Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
11-Digit NDC Billing Format:
00115131608
NDC to RxNorm Crosswalk:
  • RxCUI: 977874 - oxyMORphone HCl 10 MG 12HR Extended Release Oral Tablet
  • RxCUI: 977874 - 12 HR oxymorphone hydrochloride 10 MG Extended Release Oral Tablet
  • RxCUI: 977874 - oxymorphone hydrochloride 10 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 977894 - oxyMORphone HCl 15 MG 12HR Extended Release Oral Tablet
  • RxCUI: 977894 - 12 HR oxymorphone hydrochloride 15 MG Extended Release Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Of New York Llc
    Dosage Form:
    Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA079087
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-02-2013
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0115-1316-01100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
    0115-1316-031000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
    0115-1316-1360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0115-1316-08?

    The NDC Packaged Code 0115-1316-08 is assigned to a package of 30 tablet, film coated, extended release in 1 bottle of Oxymorphone Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

    Is NDC 0115-1316 included in the NDC Directory?

    Yes, Oxymorphone Hydrochloride with product code 0115-1316 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Of New York Llc on January 02, 2013 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0115-1316-08?

    The 11-digit format is 00115131608. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20115-1316-085-4-200115-1316-08