Pioglitazone NDC 42291-961

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-961Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0961Add 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
42291-961-30	42291096130	30 TABLET in 1 BOTTLE (42291-961-30)Marketed from Sep 17, 2024
42291-961-50	42291096150	500 TABLET in 1 BOTTLE (42291-961-50)Marketed from Sep 17, 2024

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
Generic name (nonproprietary): pioglitazone
Active ingredients: Pioglitazone hydrochloride — 45 mg/1
Dosage form: Tablet
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077210
Marketing start: Sep 17, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Thiazolidinediones (Chemical structure)
Identifiers: Product ID 42291-961_48c10047-554b-2c47-e063-6394a90ac913SPL ID 48c10047-554b-2c47-e063-6394a90ac913SPL set ID 22569835-bc9f-7787-e063-6394a90a6232RxCUI 312440, 312441, 317573UNII JQT35NPK6CUPC 0342291961500, 0342291959309, 0342291961302, 0342291960305, 0342291959903, 0342291960909
Pharmacologic class: Peroxisome Proliferator Receptor alpha Agonist; Peroxisome Proliferator Receptor gamma Agonist; 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

N442291096130 followed by a unit qualifier and the quantity

Package 42291-0961-30. 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 Jan 19, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Monotherapy and Combination Therapy Pioglitazone tablets are 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 exert their 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 ) ]. Pioglitazone tablets are a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077210

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

FDA NDC Directory listings under ANDA 077210
Product	Strength	Form · route	Labeler	Product NDC
Pioglitazone	Pioglitazone hydrochloride 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-1333
Pioglitazone	Pioglitazone hydrochloride 15 mg/1	TabletOral	AvKARE	42291-959
Pioglitazone	Pioglitazone hydrochloride 30 mg/1	TabletOral	AvKARE	42291-960
Pioglitazone	Pioglitazone hydrochloride 30 mg/1	TabletOral	American Health Packaging	60687-905
Pioglitazone	Pioglitazone hydrochloride 15 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5245
Pioglitazone	Pioglitazone hydrochloride 15 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-7271
Pioglitazone	Pioglitazone hydrochloride 30 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-7272
Pioglitazone	Pioglitazone hydrochloride 30 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2373
Pioglitazone	Pioglitazone hydrochloride 45 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-7273
Pioglitazone	Pioglitazone hydrochloride 15 mg/1	TabletOral	American Health Packaging	60687-391