Pioglitazone NDC 57237-219

NDC codes

FDA NDC Directory

Product NDC (as listed)57237-219Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57237-0219Add 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
57237-219-05	57237021905	500 TABLET in 1 BOTTLE (57237-219-05)Marketed from Feb 13, 2013
57237-219-30	57237021930	30 TABLET in 1 BOTTLE (57237-219-30)Marketed from Feb 13, 2013
57237-219-90	57237021990	90 TABLET in 1 BOTTLE (57237-219-90)Marketed from Jun 12, 2019

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 — 15 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200268
Marketing start: Feb 13, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Thiazolidinediones (Chemical structure)
Identifiers: Product ID 57237-219_f3308268-8023-434e-8caf-734ca298b98eSPL ID f3308268-8023-434e-8caf-734ca298b98eSPL set ID 4483b1c6-7095-4a63-8128-ac2d91e11040RxCUI 312440, 312441, 317573UNII JQT35NPK6CUPC 0357237221303, 0357237220306, 0357237219300
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

N457237021905 followed by a unit qualifier and the quantity

Package 57237-0219-05. 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 May 17, 2025. 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 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) ] . Pioglitazone is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma ind…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200268

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

FDA NDC Directory listings under ANDA 200268
Product	Strength	Form · route	Labeler	Product NDC
Pioglitazone	Pioglitazone hydrochloride 15 mg/1	TabletOral	A-S Medication Solutions	50090-4605
Pioglitazone	Pioglitazone hydrochloride 15 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-495
Pioglitazone	Pioglitazone hydrochloride 30 mg/1	TabletOral	DIRECT RX	72189-105
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 45 mg/1	TabletOral	A-S Medication Solutions	50090-6384
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 15 mg/1	TabletOral	A-S Medication Solutions	50090-6386
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 30 mg/1	TabletOral	A-S Medication Solutions	50090-6393
Pioglitazone	Pioglitazone hydrochloride 30 mg/1	TabletOral	REMEDYREPACK INC.	70518-2129
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 15 mg/1	TabletOral	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-103
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 30 mg/1	TabletOral	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-104
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 45 mg/1	TabletOral	QUALLENT PHARMACEUTICALS HEALTH LLC	82009-105
Pioglitazone	Pioglitazone hydrochloride 15 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5199
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 45 mg/1	TabletOral	REMEDYREPACK INC.	70518-4519
Pioglitazone	Pioglitazone hydrochloride 30 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5210
Pioglitazone	Pioglitazone hydrochloride 15 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-7511
Pioglitazone	Pioglitazone hydrochloride 30 mg/1	TabletOral	Preferred Pharmaceuticals, Inc.	68788-7514
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 45 mg/1	TabletOral	Aurobindo Pharma Limited	65862-514
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 15 mg/1	TabletOral	Aurobindo Pharma Limited	65862-512
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 30 mg/1	TabletOral	Aurobindo Pharma Limited	65862-513
Pioglitazone Hydrochloride	Pioglitazone hydrochloride 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-9664
Pioglitazone	Pioglitazone hydrochloride 15 mg/1	TabletOral	REMEDYREPACK INC.	70518-2609

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