Alcaftadine Solution/ Drops
NDC Package 62332-147-03

11-digit billing NDC: 62332014703
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Alcaftadine solution/ dropses is adults and children 2 years of age and older: put 1 drop in the affected eye(s) once dailyif using other ophthalmic products while using this product, wait at least 5 minutes between each productreplace cap after each usechildren under 2 years of age: consult a doctor. This formulation utilizes a solution/ drops delivery system. Marketed by Alembic Pharmaceuticals Inc., this product is identified by NDC 62332-147 and is authorized under FDA application ANDA209290.

Identification & Billing

NDC Package Code
62332-147-03
Package Description
1 BOTTLE in 1 CARTON / 3 mL in 1 BOTTLE
Product Code
62332-147
11-Digit Billing Format
62332014703
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Alcaftadine
Non-Proprietary Name
Alcaftadine
Substance Name
Alcaftadine
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
ALCAFTADINE 2.5 mg/mL
Pharmacologic Class
Usage Information
Adults and children 2 years of age and older: put 1 drop in the affected eye(s) once dailyif using other ophthalmic products while using this product, wait at least 5 minutes between each productreplace cap after each usechildren under 2 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Inc.
Product Type
Human Otc Drug
FDA Application #
ANDA209290
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-02-2024
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 62332-147-03 identifies a specific commercial package of 1 bottle in 1 carton / 3 ml in 1 bottle of Alcaftadine, a human over the counter drug labeled by Alembic Pharmaceuticals Inc.. This solution/ drops is formulated for ophthalmic 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 Alembic Pharmaceuticals Inc. on October 02, 2024. The current certification is valid through December 31, 2026.

How is this Alembic Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62332014703. 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)
62332-147-03
11-Digit CMS (5-4-2)
62332-0147-03

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