Pioglitazone Hydrochloride Tablet
NDC Package 76385-178-90

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

Pioglitazone Hydrochloride tablets is monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. This formulation utilizes a tablet delivery system. Marketed by Unichem Pharmaceuticals (usa), Inc., this product is identified by NDC 76385-178 and is authorized under FDA application ANDA210165.

Identification & Billing

NDC Package Code
76385-178-90
Package Description
90 TABLET in 1 BOTTLE
Product Code
76385-178
11-Digit Billing Format
76385017890

Clinical Specifications

Proprietary Name
Pioglitazone Hydrochloride
Non-Proprietary Name
Pioglitazone Hydrochloride
Substance Name
Pioglitazone Hydrochloride
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)
PIOGLITAZONE HYDROCHLORIDE 15 mg/1
Pharmacologic Class
Usage Information
Monotherapy and Combination TherapyPioglitazone Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)].Important Limitations of Use Pioglitazone Tablets exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone Tablets should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)].

Regulatory & Marketing

Labeler Name
Unichem Pharmaceuticals (usa), Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210165
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-25-2026
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 (76385-178). Click a package code to view its specific billing and regulatory data.

76385-178-10
1000 TABLET in 1 BOTTLE
76385-178-30
30 TABLET in 1 BOTTLE
76385-178-50
500 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 76385-178-90 identifies a specific commercial package of 90 tablet in 1 bottle of Pioglitazone Hydrochloride, a human prescription drug labeled by Unichem Pharmaceuticals (usa), Inc.. This tablet is formulated for oral use and contains pioglitazone 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 Unichem Pharmaceuticals (usa), Inc. on June 25, 2026. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76385017890. 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)
76385-178-90
11-Digit CMS (5-4-2)
76385-0178-90

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