NDC Package 67296-1943-8 Ciprofloxacin And Dexamethasone

Suspension/ Drops Auricular (otic) - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
67296-1943-8
Package Description:
1 BOTTLE, DROPPER in 1 CARTON / 8 mL in 1 BOTTLE, DROPPER
Product Code:
Proprietary Name:
Ciprofloxacin And Dexamethasone
Non-Proprietary Name:
Ciprofloxacin And Dexamethasone
Substance Name:
Ciprofloxacin Hydrochloride; Dexamethasone
Usage Information:
Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension USP is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below:Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureusand Pseudomonas aeruginosa.
11-Digit NDC Billing Format:
67296194308
NDC to RxNorm Crosswalk:
  • RxCUI: 403908 - ciprofloxacin 0.3 % / dexAMETHasone 0.1 % Otic Suspension
  • RxCUI: 403908 - ciprofloxacin 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension
  • RxCUI: 403908 - ciprofloxacin (as ciprofloxacin hydrochloride) 3 MG/ML / dexamethasone 1 MG/ML Otic Suspension
  • RxCUI: 403908 - ciprofloxacin 0.3 % / dexamethasone 0.1 % Otic Suspension
Product Type:
Human Prescription Drug
Labeler Name:
Redpharm Drug
Dosage Form:
Suspension/ Drops - A suspension which is usually administered in a dropwise fashion.
Administration Route(s):
Auricular (otic) - Administration to or by way of the ear.
Sample Package:
No
FDA Application Number:
ANDA215768
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
11-01-2023
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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.

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Frequently Asked Questions

What is NDC 67296-1943-8?

The NDC Packaged Code 67296-1943-8 is assigned to a package of 1 bottle, dropper in 1 carton / 8 ml in 1 bottle, dropper of Ciprofloxacin And Dexamethasone, a human prescription drug labeled by Redpharm Drug. The product's dosage form is suspension/ drops and is administered via auricular (otic) form.

Is NDC 67296-1943 included in the NDC Directory?

Yes, Ciprofloxacin And Dexamethasone with product code 67296-1943 is active and included in the NDC Directory. The product was first marketed by Redpharm Drug on November 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 67296-1943-8?

The 11-digit format is 67296194308. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-4-167296-1943-85-4-267296-1943-08