Ranitidine Tablet, Coated
NDC Package 55111-404-40

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Ranitidine tablets is adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of waterto prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburncan be used up to twice daily (do not take more than 2 tablets in 24 hours)children under 12 years: ask a doctor. This formulation utilizes a tablet, coated delivery system. Marketed by Dr. Reddy's Laboratories Limited, this product is identified by NDC 55111-404 and is authorized under FDA application ANDA078192.

Identification & Billing

NDC Package Code
55111-404-40
Package Description
1 BOTTLE in 1 BOTTLE / 40 TABLET, COATED in 1 BOTTLE
Product Code
11-Digit Billing Format
55111040440
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ranitidine
Non-Proprietary Name
Ranitidine
Substance Name
Ranitidine Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Adults and children 12 years and over: to relieve symptoms, swallow 1 tablet with a glass of waterto prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburncan be used up to twice daily (do not take more than 2 tablets in 24 hours)children under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories Limited
Product Type
Human Otc Drug
FDA Application #
ANDA078192
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-02-2009
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 (55111-404). Click a package code to view its specific billing and regulatory data.

1 BOTTLE in 1 CARTON / 200 TABLET, COATED in 1 BOTTLE
1 BLISTER PACK in 1 CARTON / 8 TABLET, COATED in 1 BLISTER PACK
3 BLISTER PACK in 1 CARTON / 8 TABLET, COATED in 1 BLISTER PACK
1 BOTTLE in 1 CARTON / 32 TABLET, COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON / 24 TABLET, COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON / 36 TABLET, COATED in 1 BOTTLE
4 BLISTER PACK in 1 CARTON / 8 TABLET, COATED in 1 BLISTER PACK
1 BOTTLE in 1 CARTON / 50 TABLET, COATED in 1 BOTTLE
2 BOTTLE in 1 CARTON / 65 TABLET, COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON / 65 TABLET, COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON / 95 TABLET, COATED in 1 BOTTLE
1 BOTTLE in 1 CARTON / 220 TABLET, COATED in 1 BOTTLE
2 BOTTLE in 1 CARTON / 95 TABLET, COATED 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 55111-404-40 identifies a specific commercial package of 1 bottle in 1 bottle / 40 tablet, coated in 1 bottle of Ranitidine, a human over the counter drug labeled by Dr. Reddy's Laboratories Limited. This tablet, coated 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 December 02, 2009. 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: 55111040440. 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)
55111-404-40
11-Digit CMS (5-4-2)
55111-0404-40

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