Fluorescein Injection
NDC Package 70710-2045-9

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

Package Information

Fluorescein injection is 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. This formulation utilizes a injection delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-2045 and is authorized under FDA application ANDA218651.

Identification & Billing

NDC Package Code
70710-2045-9
Package Description
12 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (70710-2045-1)
Product Code
70710-2045
11-Digit Billing Format
70710204509

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
Usage Information
Fluorescein injection 10% (100 mg/mL) and 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA218651
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-02-2026
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 70710-2045-9 identifies a specific commercial package of 12 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose (70710-2045-1) of Fluorescein, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. 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 Zydus Pharmaceuticals Usa Inc. on June 02, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710204509. 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)
70710-2045-9
11-Digit CMS (5-4-2)
70710-2045-09

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