Doxycycline Hyclate Tablet, Delayed Release
NDC Package 46708-484-71

11-digit billing NDC: 46708048471
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Doxycycline Hyclate tablets is to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a tablet, delayed release delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-484 and is authorized under FDA application ANDA213075.

Identification & Billing

NDC Package Code
46708-484-71
Package Description
500 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
46708-484
11-Digit Billing Format
46708048471
RxNorm Crosswalk
  • RxCUI: 1423080 - doxycycline hyclate 200 MG Delayed Release Oral Tablet
  • RxCUI: 406524 - doxycycline hyclate 75 MG Delayed Release Oral Tablet
  • RxCUI: 434018 - doxycycline hyclate 100 MG Delayed Release Oral Tablet
  • RxCUI: 799048 - doxycycline hyclate 150 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Doxycycline Hyclate
Non-Proprietary Name
Doxycycline Hyclate
Substance Name
Doxycycline Hyclate
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DOXYCYCLINE HYCLATE 200 mg/1
Pharmacologic Class
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or disease.

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA213075
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-04-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (46708-484). Click a package code to view its specific billing and regulatory data.

46708-484-30
30 TABLET, DELAYED RELEASE in 1 BOTTLE
46708-484-31
100 TABLET, DELAYED RELEASE in 1 BOTTLE
46708-484-60
60 TABLET, DELAYED RELEASE 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 46708-484-71 identifies a specific commercial package of 500 tablet, delayed release in 1 bottle of Doxycycline Hyclate, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This tablet, delayed release 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 Alembic Pharmaceuticals Limited on January 04, 2022. The current certification is valid through December 31, 2027.

How is this Alembic Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708048471. 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)
46708-484-71
11-Digit CMS (5-4-2)
46708-0484-71

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