Acticlate Capsule
NDC Package 16110-601-01

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

Package Information

Acticlate (doxycycline hyclate) capsules is a medication used to treat a wide variety of bacterial infections, including those that cause acne. This formulation utilizes a capsule delivery system. Marketed by Aqua Pharmaceuticals, this product is identified by NDC 16110-601 and is authorized under FDA application NDA208253.

Identification & Billing

NDC Package Code
16110-601-01
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
16110-601
11-Digit Billing Format
16110060101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Acticlate Cap
Non-Proprietary Name
Doxycycline Hyclate
Substance Name
Doxycycline Hyclate
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOXYCYCLINE HYCLATE 75 mg/1
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
Aqua Pharmaceuticals
Product Type
Human Prescription Drug
FDA Application #
NDA208253
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-31-2018
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 16110-601-01 identifies a specific commercial package of 60 capsule in 1 bottle of Acticlate Cap, a human prescription drug labeled by Aqua Pharmaceuticals. This capsule is formulated for oral use and contains doxycycline hyclate 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 Aqua Pharmaceuticals on May 31, 2018. 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 Aqua Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16110060101. 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)
16110-601-01
11-Digit CMS (5-4-2)
16110-0601-01

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