Clindamycin Hcl Capsule
NDC Package 80425-0145-2

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

Package Information

Clindamycin Hcl capsules is clindamycin is used to treat a wide variety of bacterial infections. This formulation utilizes a capsule delivery system. Marketed by Advanced Rx Pharmacy Of Tennessee, Llc, this product is identified by NDC 80425-0145 and is authorized under FDA application ANDA065442.

Identification & Billing

NDC Package Code
80425-0145-2
Package Description
21 CAPSULE in 1 BOTTLE
Product Code
80425-0145
11-Digit Billing Format
80425014502
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
21 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clindamycin Hcl
Non-Proprietary Name
Clindamycin Hcl
Substance Name
Clindamycin Hydrochloride
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)
CLINDAMYCIN HYDROCHLORIDE 300 mg/1
Pharmacologic Class
Usage Information
Clindamycin is used to treat a wide variety of bacterial infections. It is an antibiotic that works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for virus 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
Advanced Rx Pharmacy Of Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA065442
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-26-2009
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 (80425-0145). Click a package code to view its specific billing and regulatory data.

80425-0145-1
30 CAPSULE in 1 BOTTLE
80425-0145-3
28 CAPSULE 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 80425-0145-2 identifies a specific commercial package of 21 capsule in 1 bottle of Clindamycin Hcl, a human prescription drug labeled by Advanced Rx Pharmacy Of Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 21 billable units per package. This capsule is formulated for oral use and contains clindamycin hydrochloride 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 Advanced Rx Pharmacy Of Tennessee, Llc on August 26, 2009. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Clindamycin is used to treat a wide variety of bacterial infections. It is an antibiotic that works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for virus 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 Advanced Rx Pharmacy Of Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80425014502. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 21 total billable units per package. 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)
80425-0145-2
11-Digit CMS (5-4-2)
80425-0145-02

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