Alcaftadine Powder
NDC Package 12502-5263-7

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Alcaftadine powders is a medication used to prevent itching of the eyes due to allergies. This formulation utilizes a powder delivery system. Marketed by Cilag Ag, this product is identified by NDC 12502-5263.

Identification & Billing

NDC Package Code
12502-5263-7
Package Description
5000 kg in 1 DRUM
Product Code
12502-5263
11-Digit Billing Format
12502526307

Clinical Specifications

Proprietary Name
Alcaftadine
Non-Proprietary Name
Alcaftadine
Substance Name
Alcaftadine
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ALCAFTADINE 1 kg/kg
Usage Information
This medication is used to prevent itching of the eyes due to allergies. Alcaftadine is an antihistamine. It works by blocking a certain natural substance (histamine) that causes allergic symptoms. Do not use this medication to treat red or irritated eyes due to wearing contact lenses. Contact your doctor for further instructions if this occurs.

Regulatory & Marketing

Labeler Name
Cilag Ag
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
01-14-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 12502-5263-7 identifies a specific commercial package of 5000 kg in 1 drum of Alcaftadine (UNFINISHED drug), a bulk ingredient labeled by Cilag Ag. This powder is formulated for use and contains alcaftadine 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 Cilag Ag on January 14, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to prevent itching of the eyes due to allergies. Alcaftadine is an antihistamine. It works by blocking a certain natural substance (histamine) that causes allergic symptoms. Do not use this medication to treat red or irritated eyes due to wearing contact lenses. Contact your doctor for further instructions if this occurs.

How is this Cilag Ag product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12502526307. 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 (5-4-1)
12502-5263-7
11-Digit CMS (5-4-2)
12502-5263-07

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