Pioglitazone And Glimepiride Tablet
NDC Package 66993-821-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Pioglitazone And Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)]. This formulation utilizes a tablet delivery system. Marketed by Prasco Laboratories, this product is identified by NDC 66993-821 and is authorized under FDA application NDA021925.

Identification & Billing

NDC Package Code
66993-821-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
11-Digit Billing Format
66993082130
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 647237 - pioglitazone HCl 30 MG / glimepiride 2 MG Oral Tablet
  • RxCUI: 647237 - glimepiride 2 MG / pioglitazone 30 MG Oral Tablet
  • RxCUI: 647237 - glimepiride 2 MG / pioglitazone (as pioglitazone hydrochloride) 30 MG Oral Tablet
  • RxCUI: 647239 - pioglitazone HCl 30 MG / glimepiride 4 MG Oral Tablet
  • RxCUI: 647239 - glimepiride 4 MG / pioglitazone 30 MG Oral Tablet

Clinical Specifications

Proprietary Name
Pioglitazone And Glimepiride
Non-Proprietary Name
Pioglitazone And Glimepiride
Substance Name
Glimepiride; 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.
Usage Information
Pioglitazone and glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Prasco Laboratories
Product Type
Human Prescription Drug
FDA Application #
NDA021925
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
08-04-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 66993-821-30 identifies a specific commercial package of 30 tablet in 1 bottle of Pioglitazone And Glimepiride, a human prescription drug labeled by Prasco Laboratories. This tablet is formulated for oral use and contains glimepiride; 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 Prasco Laboratories on August 04, 2015. The current certification is valid through December 31, 2026.

How is this Prasco Laboratories product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66993082130. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
66993-821-30
11-Digit CMS (5-4-2)
66993-0821-30

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