NDC Package 0121-4727-10 Ranitidine

Syrup 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:
0121-4727-10
Package Description:
4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE
Product Code:
Proprietary Name:
Ranitidine
Non-Proprietary Name:
Ranitidine
Substance Name:
Ranitidine
Usage Information:
Ranitidine Syrup (Ranitidine Oral Solution USP) is indicated in: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.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.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).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.Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily.Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.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:
00121472710
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 705610 - ranitidine 15 MG/ML Oral Solution
  • RxCUI: 705610 - ranitidine 15 MG (as ranitidine HCl 16.8 MG) per 1 ML Oral Solution
  • RxCUI: 705610 - ranitidine 75 MG per 5 ML Syrup
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pharmaceutical Associates, Inc.
    Dosage Form:
    Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA077405
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-01-2010
    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.

    Frequently Asked Questions

    What is NDC 0121-4727-10?

    The NDC Packaged Code 0121-4727-10 is assigned to a package of 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 ml in 1 cup, unit-dose of Ranitidine, a human prescription drug labeled by Pharmaceutical Associates, Inc.. The product's dosage form is syrup and is administered via oral form.

    Is NDC 0121-4727 included in the NDC Directory?

    Yes, Ranitidine with product code 0121-4727 is active and included in the NDC Directory. The product was first marketed by Pharmaceutical Associates, Inc. on November 01, 2010 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 0121-4727-10?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0121-4727-10?

    The 11-digit format is 00121472710. 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
    4-4-20121-4727-105-4-200121-4727-10