NDC 57237-217

NDC codes

FDA NDC Directory

Product NDC (as listed)57237-217Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57237-0217Add 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
57237-217-60	57237021760	60 TABLET, FILM COATED in 1 BOTTLE (57237-217-60)Marketed from Feb 13, 2013
57237-217-81	57237021781	180 TABLET, FILM COATED in 1 BOTTLE (57237-217-81)Marketed from Feb 13, 2013

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 Hydrochloride and Metformin Hydrochloride
Generic name (nonproprietary): pioglitazone hydrochloride and metformin hydrochloride
Active ingredients: Pioglitazone hydrochloride — 15 mg/1Metformin hydrochloride — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200823
Marketing start: Feb 13, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Thiazolidinediones (Chemical structure)
Identifiers: Product ID 57237-217_e1c4f0ca-4474-4bac-8884-8180e7aec050SPL ID e1c4f0ca-4474-4bac-8884-8180e7aec050SPL set ID 8d252dab-e868-42d3-95ea-69423d909e84RxCUI 861783, 861822UNII 786Z46389E, JQT35NPK6CUPC 0357237218600, 0357237217603
Pharmacologic class: Biguanide; 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

N457237021760 followed by a unit qualifier and the quantity

Package 57237-0217-60. 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 Feb 27, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Pioglitazone and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Pioglitazone and metformin hydrochloride tablets are not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis. Pioglitazone and metformin hydrochloride tablets are a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Not recommended 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 ANDA 200823

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

FDA NDC Directory listings under ANDA 200823
Product	Strength	Form · route	Labeler	Product NDC
Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-218
Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-526
Pioglitazone Hydrochloride and Metformin Hydrochloride	Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-525

Pioglitazone Hydrochloride and Metformin Hydrochloride NDC 57237-217