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  5. NDC Package Code: 65162-253-18 Ranitidine

NDC Package 65162-253-18 Ranitidine

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:
65162-253-18
Package Description:
180 TABLET in 1 BOTTLE
Product Code:
65162-253
Proprietary Name:
Ranitidine
Non-Proprietary Name:
Ranitidine
Substance Name:
Ranitidine Hydrochloride
Usage Information:
Ranitidine Tablets are indicated in:1.   Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.2.   Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.3.   The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).4.   Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated.Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.5.   Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.6.   Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with Ranitidine Tablets 150 mg twice daily.7.   Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with Ranitidine Tablets 150 mg 4 times daily.8.   Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
11-Digit NDC Billing Format:
65162025318
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: 198191 - ranitidine 150 MG Oral Tablet
  • RxCUI: 198191 - ranitidine 150 MG (as ranitidine HCl 168 MG) Oral Tablet
  • RxCUI: 198193 - ranitidine 300 MG Oral Tablet
  • RxCUI: 198193 - ranitidine 300 MG (as ranitidine HCl 336 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Amneal Pharmaceuticals Llc
    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):
  • RANITIDINE HYDROCHLORIDE 150 mg/1
    • Pharmacologic Class(es):
  • Histamine H2 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-2 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA077824
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-16-2009
    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
    65162-253-0660 TABLET in 1 BOTTLE
    65162-253-10100 TABLET in 1 BOTTLE
    65162-253-111000 TABLET in 1 BOTTLE
    65162-253-50500 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65162-253-18?

    The NDC Packaged Code 65162-253-18 is assigned to a package of 180 tablet in 1 bottle of Ranitidine, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 65162-253 included in the NDC Directory?

    Yes, Ranitidine with product code 65162-253 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on December 16, 2009 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 NDC billing unit for package 65162-253-18?

    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 65162-253-18?

    The 11-digit format is 65162025318. 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
    5-3-265162-253-185-4-265162-0253-18