Ciprofloxacin Tablet
NDC Package 83008-078-20

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Ciprofloxacin (ciprofolxacin) tablets is a medication used to treat a variety of bacterial infections. This formulation utilizes a tablet delivery system. Marketed by Quality Care Products, Llc, this product is identified by NDC 83008-078 and is authorized under FDA application ANDA208921.

Identification & Billing

NDC Package Code
83008-078-20
Package Description
20 TABLET in 1 BOTTLE
Product Code
83008-078
11-Digit Billing Format
83008007820
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
20 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ciprofloxacin
Non-Proprietary Name
Ciprofolxacin
Substance Name
Ciprofloxacin Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CIPROFLOXACIN HYDROCHLORIDE 500 mg/1
Pharmacologic Class
Usage Information
This medication is used to treat a variety of bacterial infections. Ciprofloxacin belongs to a class of drugs called quinolone antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for virus infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Regulatory & Marketing

Labeler Name
Quality Care Products, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA208921
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-21-2024
End Marketing Date
08-31-2026
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 83008-078-20 identifies a specific commercial package of 20 tablet in 1 bottle of Ciprofloxacin, a human prescription drug labeled by Quality Care Products, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 20 billable units per package. This tablet is formulated for oral use and contains ciprofloxacin hydrochloride 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 Quality Care Products, Llc on August 21, 2024.

What are the primary indications for this medication?

This medication is used to treat a variety of bacterial infections. Ciprofloxacin belongs to a class of drugs called quinolone antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for virus infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How is this Quality Care Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83008007820. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 20 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)
83008-078-20
11-Digit CMS (5-4-2)
83008-0078-20

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