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  5. NDC Package Code: 0115-1320-19 Colesevelam Hydrochloride

NDC Package 0115-1320-19 Colesevelam Hydrochloride

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
0115-1320-19
Package Description:
180 TABLET, COATED in 1 BOTTLE
Product Code:
0115-1320
Proprietary Name:
Colesevelam Hydrochloride
Non-Proprietary Name:
Colesevelam Hydrochloride
Substance Name:
Colesevelam Hydrochloride
Usage Information:
Colesevelam hydrochloride is contraindicated in patients with: Serum TG concentrations > 500 mg/dL [see Warnings and Precautions (5.1)] History of hypertriglyceridemia-induced pancreatitis [see Warnings and Precautions (5.1)] A history of bowel obstruction [see Warnings and Precautions (5.2)]
11-Digit NDC Billing Format:
00115132019
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
180 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 866910 - colesevelam HCl 625 MG Oral Tablet
  • RxCUI: 866910 - colesevelam hydrochloride 625 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Of New York Llc
    Dosage Form:
    Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • COLESEVELAM HYDROCHLORIDE 625 mg/1
    • Pharmacologic Class(es):
  • Bile Acid Sequestrant - [EPC] (Established Pharmacologic Class)
  • Bile-acid Binding Activity - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA091600
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-17-2018
    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.

    Frequently Asked Questions

    What is NDC 0115-1320-19?

    The NDC Packaged Code 0115-1320-19 is assigned to a package of 180 tablet, coated in 1 bottle of Colesevelam Hydrochloride, a human prescription drug labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 0115-1320 included in the NDC Directory?

    Yes, Colesevelam Hydrochloride with product code 0115-1320 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Of New York Llc on May 17, 2018 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 NDC billing unit for package 0115-1320-19?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 180.

    What is the 11-digit format for NDC 0115-1320-19?

    The 11-digit format is 00115132019. 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
    4-4-20115-1320-195-4-200115-1320-19