Doxycycline Hyclate Powder, For Solution
NDC Package 70436-201-82

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

Package Information

Doxycycline Hyclate powders is a medication used to treat a wide variety of bacterial infections, including those that cause acne. This formulation utilizes a powder, for solution delivery system. Marketed by Slate Run Pharmaceuticals, Llc, this product is identified by NDC 70436-201 and is authorized under FDA application ANDA217685.

Identification & Billing

NDC Package Code
70436-201-82
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE (70436-201-36)
Product Code
70436-201
11-Digit Billing Format
70436020182

Clinical Specifications

Proprietary Name
Doxycycline Hyclate
Non-Proprietary Name
Doxycycline Hyclate
Substance Name
Doxycycline Anhydrous
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DOXYCYCLINE ANHYDROUS 200 mg/20mL
Pharmacologic Class
Usage Information
This medication is used to treat a wide variety of bacterial infections, including those that cause acne. This medication is also used to prevent malaria. This medication is known as a tetracycline antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral 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
Slate Run Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA217685
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-22-2024
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 70436-201-82 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose (70436-201-36) of Doxycycline Hyclate, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. This powder, for solution is formulated for intravenous use and contains doxycycline anhydrous 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 Slate Run Pharmaceuticals, Llc on July 22, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a wide variety of bacterial infections, including those that cause acne. This medication is also used to prevent malaria. This medication is known as a tetracycline antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral 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 Slate Run Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70436020182. 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)
70436-201-82
11-Digit CMS (5-4-2)
70436-0201-82

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