Cephalexin For Suspension
NDC Package 70518-4511-0

11-digit billing NDC: 70518451100
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Cephalexin for suspensions is 125 mg /5 mL (100 mL when mixed):Prepare suspension time at dispensing. This formulation utilizes a for suspension delivery system. Marketed by Remedyrepack Inc., this product is identified by NDC 70518-4511 and is authorized under FDA application ANDA210221.

Identification & Billing

NDC Package Code
70518-4511-0
Package Description
100 mL in 1 BOTTLE
Product Code
70518-4511
11-Digit Billing Format
70518451100
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cephalexin
Non-Proprietary Name
Cephalexin
Substance Name
Cephalexin
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)
CEPHALEXIN 250 mg/5mL
Pharmacologic Class
Usage Information
125 mg /5 mL (100 mL when mixed):Prepare suspension time at dispensing. Add to the bottle a total of 67 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 125 mg cephalexin in each 5 mL (teaspoonful). 125 mg /5 mL (200 mL when mixed):Prepare suspension time at dispensing. Add to the bottle a total of 134 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 125 mg cephalexin in each 5 mL (teaspoonful). 250 mg /5 mL (100 mL when mixed):Prepare suspension time at dispensing. Add to the bottle a total of 67 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin  monohydrate equivalent to 250 mg cephalexin in each 5 mL (teaspoonful). 250 mg /5 mL (200 mL when mixed):Prepare suspension time at dispensing. Add to the bottle a total of 134 mL of water. For ease in preparation, tap bottle to loosen powder, add the water in 2 portions, shaking well after each addition. The resulting suspension will contain cephalexin monohydrate equivalent to 250 mg cephalexin in each 5 mL (teaspoonful).  After mixing the different concentrations and volumes of the suspension as described above, store in refrigerator. The suspension may be kept for 14 days without significant loss of potency.

Regulatory & Marketing

Labeler Name
Remedyrepack Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210221
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-28-2025
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 70518-4511-0 identifies a specific commercial package of 100 ml in 1 bottle of Cephalexin, a human prescription drug labeled by Remedyrepack Inc.. This for suspension is formulated for oral use and contains cephalexin 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 Remedyrepack Inc. on October 28, 2025. The current certification is valid through December 31, 2027.

How is this Remedyrepack Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70518451100. 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)
70518-4511-0
11-Digit CMS (5-4-2)
70518-4511-00

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