Cefaclor Suspension
NDC Package 81948-6250-1

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

Package Information

Cefaclor suspension is a medication a cephalosporin-type antibiotic used to treat a wide variety of bacterial infections (e.g., middle ear, skin, urine and respiratory tract infections). This formulation utilizes a suspension delivery system. Marketed by Azorian Pharma, Llc, this product is identified by NDC 81948-6250 and is authorized under FDA application ANDA065412.

Identification & Billing

NDC Package Code
81948-6250-1
Package Description
150 mL in 1 BOTTLE
Product Code
81948-6250
11-Digit Billing Format
81948625001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
150 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefaclor
Non-Proprietary Name
Cefaclor
Substance Name
Cefaclor
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CEFACLOR 250 mg/5mL
Pharmacologic Class
Usage Information
This medication is a cephalosporin-type antibiotic used to treat a wide variety of bacterial infections (e.g., middle ear, skin, urine and respiratory tract infections). It works by stopping the growth of bacteria. This antibiotic only treats bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Azorian Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065412
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-01-2022
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 81948-6250-1 identifies a specific commercial package of 150 ml in 1 bottle of Cefaclor, a human prescription drug labeled by Azorian Pharma, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 150 billable units per package. This suspension is formulated for oral use and contains cefaclor 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 Azorian Pharma, Llc on November 01, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a cephalosporin-type antibiotic used to treat a wide variety of bacterial infections (e.g., middle ear, skin, urine and respiratory tract infections). It works by stopping the growth of bacteria. This antibiotic only treats bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

How is this Azorian Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81948625001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 150 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 (5-4-1)
81948-6250-1
11-Digit CMS (5-4-2)
81948-6250-01

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