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  5. NDC Package Code: 13668-397-05 Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg

NDC Package 13668-397-05 Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg

Olmesartan Medoxomil,Amlodipine And Hydrochlorothiazide Tablet 20/5/12.5 Mg Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
13668-397-05
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
13668-397
Proprietary Name:
Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg
Non-Proprietary Name:
Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide Tablet 20/5/12.5 Mg
Substance Name:
Amlodipine; Hydrochlorothiazide; Olmesartan Medoxomil
11-Digit NDC Billing Format:
13668039705
NDC to RxNorm Crosswalk:
  • RxCUI: 1000001 - olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral Tablet
  • RxCUI: 1000001 - amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet
  • RxCUI: 1000001 - amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet
  • RxCUI: 1000001 - Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet
  • RxCUI: 999967 - olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Torrent Pharmaceuticals Limited
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • AMLODIPINE 5 mg/1
  • HYDROCHLOROTHIAZIDE 12.5 mg/1
  • OLMESARTAN MEDOXOMIL 20 mg/1
    • Pharmacologic Class(es):
  • Angiotensin 2 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Angiotensin 2 Receptor Blocker - [EPC] (Established Pharmacologic Class)
  • Calcium Channel Antagonists - [MoA] (Mechanism of Action)
  • Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
  • Cytochrome P450 3A Inhibitors - [MoA] (Mechanism of Action)
  • Dihydropyridine Calcium Channel Blocker - [EPC] (Established Pharmacologic Class)
  • Dihydropyridines - [CS]
  • Increased Diuresis - [PE] (Physiologic Effect)
  • Thiazide Diuretic - [EPC] (Established Pharmacologic Class)
  • Thiazides - [CS]
    • Sample Package:
    No
    FDA Application Number:
    ANDA203580
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-26-2016
    Listing Expiration Date:
    12-31-2024
    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
    13668-397-3030 TABLET in 1 BOTTLE
    13668-397-9090 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 13668-397-05?

    The NDC Packaged Code 13668-397-05 is assigned to a package of 500 tablet in 1 bottle of Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg, a human prescription drug labeled by Torrent Pharmaceuticals Limited. The product's dosage form is tablet and is administered via oral form.

    Is NDC 13668-397 included in the NDC Directory?

    Yes, Olmesartan Medoxomil, Amlodipine And Hydrochlorothiazide 20/5/12.5 Mg with product code 13668-397 is active and included in the NDC Directory. The product was first marketed by Torrent Pharmaceuticals Limited on October 26, 2016 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 13668-397-05?

    The 11-digit format is 13668039705. 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 5-3-2 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
    5-3-213668-397-055-4-213668-0397-05