Cefixime Powder, For Suspension
NDC Package 65862-751-01

11-digit billing NDC: 65862075101
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Cefixime powders is strengthBottle SizeReconstitution Directions100 mg/5 mL 100 mLTo reconstitute, suspend with 70 mL water. This formulation utilizes a powder, for suspension delivery system. Marketed by Aurobindo Pharma Limited, this product is identified by NDC 65862-751 and is authorized under FDA application ANDA204835.

Identification & Billing

NDC Package Code
65862-751-01
Package Description
100 mL in 1 BOTTLE
Product Code
65862-751
11-Digit Billing Format
65862075101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cefixime
Non-Proprietary Name
Cefixime
Substance Name
Cefixime
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CEFIXIME 100 mg/5mL
Pharmacologic Class
Usage Information
StrengthBottle SizeReconstitution Directions100 mg/5 mL 100 mLTo reconstitute, suspend with 70 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.200 mg/5 mL75 mLTo reconstitute, suspend with 52.5 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.100 mg/5 mL and 200 mg/5 mL50 mLTo reconstitute, suspend with 35 mL water. Method: Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half the total amount of water for reconstitution and shake well. Add the remainder of water and shake well.After reconstitution, the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.

Regulatory & Marketing

Labeler Name
Aurobindo Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA204835
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-14-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65862-751). Click a package code to view its specific billing and regulatory data.

65862-751-50
50 mL in 1 BOTTLE

* 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 65862-751-01 identifies a specific commercial package of 100 ml in 1 bottle of Cefixime, a human prescription drug labeled by Aurobindo Pharma Limited. This powder, for suspension is formulated for oral use and contains cefixime 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 Aurobindo Pharma Limited on April 14, 2015. The current certification is valid through December 31, 2026.

How is this Aurobindo Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65862075101. 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)
65862-751-01
11-Digit CMS (5-4-2)
65862-0751-01

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