Ranitidine Hydrochloride Capsule
NDC Package 55111-129-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Ranitidine Hydrochloride capsules is   Ranitidine is indicated in:   1. This formulation utilizes a capsule delivery system. Marketed by Dr. Reddy's Laboratories Limited, this product is identified by NDC 55111-129 and is authorized under FDA application ANDA075742.

Identification & Billing

NDC Package Code
55111-129-60
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
55111-129
11-Digit Billing Format
55111012960
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ranitidine Hydrochloride
Non-Proprietary Name
Ranitidine Hydrochloride
Substance Name
Ranitidine Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
RANITIDINE HYDROCHLORIDE 150 mg/1
Pharmacologic Class
Usage Information
  Ranitidine is 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 150 mg two times a day.  7. 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.  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.

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA075742
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-12-2001
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55111-129). Click a package code to view its specific billing and regulatory data.

55111-129-05
500 CAPSULE in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55111-129-60 identifies a specific commercial package of 60 capsule in 1 bottle of Ranitidine Hydrochloride, a human prescription drug labeled by Dr. Reddy's Laboratories Limited. This capsule is formulated for oral use and contains ranitidine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Dr. Reddy's Laboratories Limited on January 12, 2001. The current certification is valid through December 31, 2026.

How is this Dr. Reddy's Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111012960. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
55111-129-60
11-Digit CMS (5-4-2)
55111-0129-60

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.