pioglitazone and glimepiride NDC 66993-822

NDC codes

FDA NDC Directory

Product NDC (as listed)66993-822Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66993-0822Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
66993-822-30	66993082230	30 TABLET in 1 BOTTLE (66993-822-30)Marketed from Aug 4, 2015

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): pioglitazone and glimepiride
Generic name (nonproprietary): pioglitazone and glimepiride
Active ingredients: Pioglitazone hydrochloride — 30 mg/1Glimepiride — 4 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Prasco Laboratories
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021925
Marketing start: Aug 4, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Sulfonylurea Compounds (Chemical structure)Thiazolidinediones (Chemical structure)
Identifiers: Product ID 66993-822_370e643e-7cf8-4a0a-b6c4-78e96162c48fSPL ID 370e643e-7cf8-4a0a-b6c4-78e96162c48fSPL set ID ea385b3d-cb4c-4550-97b0-93a86533f6dcRxCUI 647237, 647239UNII JQT35NPK6C, 6KY687524KUPC 0366993822303, 0366993821306
Pharmacologic class: Peroxisome Proliferator Receptor alpha Agonist; Peroxisome Proliferator Receptor gamma Agonist; Sulfonylurea; Thiazolidinedione

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N466993082230 followed by a unit qualifier and the quantity

Package 66993-0822-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Dec 12, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

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) ] . Pioglitazone and glimepiride tablets are a thiazolidinedione and a sulfonylurea combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and glimepiride is appropriate. ( 1 ) Important Limitations of Use: Not for treatment of type 1 diabetes …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021925

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021925
Product	Strength	Form · route	Labeler	Product NDC
pioglitazone and glimepiride	Pioglitazone hydrochloride 30 mg/1; Glimepiride 2 mg/1	TabletOral	Prasco Laboratories	66993-821
Duetactpioglitazone and glimepiride	Pioglitazone hydrochloride 30 mg/1; Glimepiride 2 mg/1	TabletOral	Takeda Pharmaceuticals America, Inc.	64764-302
Duetactpioglitazone and glimepiride	Pioglitazone hydrochloride 30 mg/1; Glimepiride 4 mg/1	TabletOral	Takeda Pharmaceuticals America, Inc.	64764-304