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  5. NDC Package Code: 50383-966-08 Cimetidine Hydrochloride

NDC Package 50383-966-08 Cimetidine Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
50383-966-08
Package Description:
273 mL in 1 BOTTLE
Product Code:
50383-966
Proprietary Name:
Cimetidine Hydrochloride
Usage Information:
Cimetidine Hydrochloride Oral Solution is indicated in:(1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see Dosage and Administration-Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine.(2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to 5 years.(3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks.(4) Erosive gastroesophageal reflux disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of cimetidine beyond 12 weeks has not been established (see Dosage and Administration-GERD).(5) The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).
11-Digit NDC Billing Format:
50383096608
NDC to RxNorm Crosswalk:
  • RxCUI: 212787 - cimetidine HCl 300 MG in 5 mL Oral Solution
  • RxCUI: 212787 - cimetidine 60 MG/ML Oral Solution
  • RxCUI: 212787 - cimetidine 300 MG per 5 ML Oral Solution
  • RxCUI: 212787 - cimetidine 400 MG per 6.7 ML Oral Solution
    • Labeler Name:
    Akorn
    Sample Package:
    No
    Start Marketing Date:
    10-29-2020
    Listing Expiration Date:
    12-31-2023
    Exclude Flag:
    I
    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 50383-966-08?

    The NDC Packaged Code 50383-966-08 is assigned to a package of 273 ml in 1 bottle of Cimetidine Hydrochloride, labeled by Akorn. The product's dosage form is and is administered via form.

    Is NDC 50383-966 included in the NDC Directory?

    No, Cimetidine Hydrochloride with product code 50383-966 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Akorn on October 29, 2020 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 50383-966-08?

    The 11-digit format is 50383096608. 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
    5-3-250383-966-085-4-250383-0966-08