Fenofibric Acid Capsule, Delayed Release
NDC Package 46708-245-90

11-digit billing NDC: 46708024590
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fenofibric Acid capsules is fenofibric acid delayed-release capsules are contraindicated in:·         patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology (12.3)].·         patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions (5.3)].·         patients with preexisting gallbladder disease [see Warnings and Precautions (5.5)].·         nursing mothers [see Use in Specific Populations (8.3)].·         patients with hypersensitivity to fenofibric acid or fenofibrate [see Warnings and Precautions (5.9)]. . This formulation utilizes a capsule, delayed release delivery system. Marketed by Alembic Pharmaceuticals Limited, this product is identified by NDC 46708-245 and is authorized under FDA application ANDA208705.

Identification & Billing

NDC Package Code
46708-245-90
Package Description
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Product Code
46708-245
11-Digit Billing Format
46708024590
RxNorm Crosswalk
  • RxCUI: 828373 - fenofibric acid 135 MG Delayed Release Oral Capsule
  • RxCUI: 828379 - fenofibric acid 45 MG Delayed Release Oral Capsule

Clinical Specifications

Proprietary Name
Fenofibric Acid
Non-Proprietary Name
Fenofibric Acid
Substance Name
Fenofibric Acid
Dosage Form
Capsule, Delayed Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and 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)
FENOFIBRIC ACID 135 mg/1
Pharmacologic Class
Peroxisome Proliferator Receptor alpha Agonist - [EPC] (Established Pharmacologic Class)
Usage Information
Fenofibric acid delayed-release capsules are contraindicated in:·         patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology (12.3)].·         patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions (5.3)].·         patients with preexisting gallbladder disease [see Warnings and Precautions (5.5)].·         nursing mothers [see Use in Specific Populations (8.3)].·         patients with hypersensitivity to fenofibric acid or fenofibrate [see Warnings and Precautions (5.9)]. 

Regulatory & Marketing

Labeler Name
Alembic Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA208705
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-18-2017
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 (46708-245). Click a package code to view its specific billing and regulatory data.

46708-245-30
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE
46708-245-91
1000 CAPSULE, 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 46708-245-90 identifies a specific commercial package of 90 capsule, delayed release in 1 bottle of Fenofibric Acid, a human prescription drug labeled by Alembic Pharmaceuticals Limited. This capsule, delayed release is formulated for oral use and contains fenofibric acid 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 May 18, 2017. 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: 46708024590. 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)
46708-245-90
11-Digit CMS (5-4-2)
46708-0245-90

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