Fluorescein Injection
NDC Package 83854-048-12

11-digit billing NDC: 83854004812
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fluorescein injection is classified as a

administered via intravenous route. This formulation utilizes a injection delivery system. Marketed by Anthea Pharma Private Limited, this product is identified by NDC 83854-048 and is authorized under FDA application ANDA218651.

Identification & Billing

NDC Package Code
83854-048-12
Package Description
12 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (83854-048-01)
Product Code
83854-048
11-Digit Billing Format
83854004812

Clinical Specifications

Proprietary Name
Fluorescein
Non-Proprietary Name
Fluorescein
Substance Name
Fluorescein Sodium
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
FLUORESCEIN SODIUM 100 mg/mL
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Anthea Pharma Private Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA218651
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-14-2026
Listing Expiration
12-31-2027
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 83854-048-12 identifies a specific commercial package of 12 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (83854-048-01) of Fluorescein, a human prescription drug labeled by Anthea Pharma Private Limited. This injection is formulated for intravenous use and contains fluorescein sodium 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 Anthea Pharma Private Limited on October 14, 2026. The current certification is valid through December 31, 2027.

How is this Anthea Pharma Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83854004812. 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)
83854-048-12
11-Digit CMS (5-4-2)
83854-0048-12

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