Nuzolvence For Suspension
NDC Package 68547-915-10

11-digit billing NDC: 68547091510 · Billing unit: EA · 1 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nuzolvence (zoliflodacin) for suspensions is nUZOLVENCE is contraindicated in:patients with a known history of hypersensitivity to NUZOLVENCE [see Warnings and Precautions (5.4)].patients who use concomitant moderate or strong CYP3A4 inducers because concomitant use is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the efficacy of NUZOLVENCE [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. This formulation utilizes a for suspension delivery system. Marketed by La Jolla Pharmaceutical Company, this product is identified by NDC 68547-915 and is authorized under FDA application NDA219491.

Identification & Billing

NDC Package Code
68547-915-10
Package Description
1 PACKET in 1 CARTON / 1 FOR SUSPENSION in 1 PACKET
Product Code
68547-915
11-Digit Billing Format
68547091510
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nuzolvence
Non-Proprietary Name
Zoliflodacin
Substance Name
Zoliflodacin
Dosage Form
For Suspension - A product, usually a solid, intended for suspension prior to administration.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZOLIFLODACIN 3 g/1
Usage Information
NUZOLVENCE is contraindicated in:patients with a known history of hypersensitivity to NUZOLVENCE [see Warnings and Precautions (5.4)].patients who use concomitant moderate or strong CYP3A4 inducers because concomitant use is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the efficacy of NUZOLVENCE [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Regulatory & Marketing

Labeler Name
La Jolla Pharmaceutical Company
Product Type
Human Prescription Drug
FDA Application #
NDA219491
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-09-2026
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 68547-915-10 identifies a specific commercial package of 1 packet in 1 carton / 1 for suspension in 1 packet of Nuzolvence, a human prescription drug labeled by La Jolla Pharmaceutical Company. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This for suspension is formulated for oral use and contains zoliflodacin 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 La Jolla Pharmaceutical Company on October 09, 2026. The current certification is valid through December 31, 2027.

How is this La Jolla Pharmaceutical Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68547091510. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
68547-915-10
11-Digit CMS (5-4-2)
68547-0915-10

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