Telmisartan And Hydrochlorothiazide Tablet
NDC Package 46708-210-91

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

Telmisartan And Hydrochlorothiazide tablets is uSP are indicated for the treatment of hypertension. This formulation utilizes a tablet delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-210 and is authorized under FDA application ANDA203010.

Identification & Billing

NDC Package Code
46708-210-91
Package Description
1000 TABLET in 1 BOTTLE
Product Code
46708-210
11-Digit Billing Format
46708021091
RxNorm Crosswalk
  • RxCUI: 283316 - telmisartan 40 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 283316 - hydrochlorothiazide 12.5 MG / telmisartan 40 MG Oral Tablet
  • RxCUI: 283316 - HCTZ 12.5 MG / telmisartan 40 MG Oral Tablet
  • RxCUI: 283317 - telmisartan 80 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet
  • RxCUI: 283317 - hydrochlorothiazide 12.5 MG / telmisartan 80 MG Oral Tablet

Clinical Specifications

Proprietary Name
Telmisartan And Hydrochlorothiazide
Non-Proprietary Name
Telmisartan And Hydrochlorothiazide
Substance Name
Hydrochlorothiazide; Telmisartan
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Telmisartan and hydrochlorothiazide tablets, USP are indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA203010
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-14-2014
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 (46708-210). Click a package code to view its specific billing and regulatory data.

46708-210-10
100 TABLET in 1 CARTON
46708-210-30
30 TABLET 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 46708-210-91 identifies a specific commercial package of 1000 tablet in 1 bottle of Telmisartan And Hydrochlorothiazide, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This tablet is formulated for oral use and contains hydrochlorothiazide; telmisartan 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 March 14, 2014. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46708021091. 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)
46708-210-91
11-Digit CMS (5-4-2)
46708-0210-91

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