Minocycline Hydrochloride Tablet, Extended Release
NDC Package 68382-552-01

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

Minocycline Hydrochloride tablets is minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. This formulation utilizes a tablet, extended release delivery system. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 68382-552 and is authorized under FDA application ANDA203553.

Identification & Billing

NDC Package Code
68382-552-01
Package Description
100 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code
68382-552
11-Digit Billing Format
68382055201
RxNorm Crosswalk
  • RxCUI: 1013659 - minocycline HCl 105 MG 24HR Extended Release Oral Tablet
  • RxCUI: 1013659 - 24 HR minocycline 105 MG Extended Release Oral Tablet
  • RxCUI: 1013659 - minocycline 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral Tablet
  • RxCUI: 1013659 - minocycline 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 1013659 - minocycline 105 MG 24 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Minocycline Hydrochloride
Non-Proprietary Name
Minocycline Hydrochloride
Substance Name
Minocycline Hydrochloride
Dosage Form
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MINOCYCLINE HYDROCHLORIDE 105 mg/1
Pharmacologic Class
Usage Information
Minocycline hydrochloride extended-release tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

Regulatory & Marketing

Labeler Name
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203553
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-07-2018
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68382-552). Click a package code to view its specific billing and regulatory data.

68382-552-05
500 TABLET, EXTENDED RELEASE in 1 BOTTLE
68382-552-06
30 TABLET, EXTENDED RELEASE in 1 BOTTLE
68382-552-10
1000 TABLET, EXTENDED RELEASE in 1 BOTTLE
68382-552-16
90 TABLET, EXTENDED RELEASE in 1 BOTTLE
68382-552-30
10 BLISTER PACK in 1 CARTON / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

* 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 68382-552-01 identifies a specific commercial package of 100 tablet, extended release in 1 bottle of Minocycline Hydrochloride, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. This tablet, extended release is formulated for oral use and contains minocycline 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 Zydus Pharmaceuticals (usa) Inc. on March 07, 2018. The current certification is valid through December 31, 2026.

How is this Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68382055201. 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)
68382-552-01
11-Digit CMS (5-4-2)
68382-0552-01

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