Pioglitazone and metformin hydrochloride NDC 71335-3019

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-3019Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-3019Add 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
71335-3019-1	71335301901	180 TABLET in 1 BOTTLE (71335-3019-1)Marketed from Dec 3, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 metformin hydrochloride
Generic name (nonproprietary): pioglitazone and metformin hydrochloride
Active ingredients: Pioglitazone hydrochloride — 15 mg/1Metformin hydrochloride — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch Prepack
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204802
Marketing start: Nov 6, 2015
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 71335-3019_7c59377b-a0cb-48b3-af4f-95f64d0f4ad1SPL ID 7c59377b-a0cb-48b3-af4f-95f64d0f4ad1SPL set ID 8080eedb-e955-4059-98b2-9685b608eb3eRxCUI 861783UNII JQT35NPK6C, 786Z46389E
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

N471335301901 followed by a unit qualifier and the quantity

Package 71335-3019-01. 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 3, 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 is not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis. Pioglitazone and metformin hydrochloride tablets are a thiazolidinedione and biguanide 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 metformin is appropriate. ( 1 , 14 ) Limitations of Use : • Not for treatment of type 1 diabetes or diabetic ketoacidosis. ( …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204802

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

FDA NDC Directory listings under ANDA 204802
Product	Strength	Form · route	Labeler	Product NDC
Pioglitazole and metformin hydrochloride	Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	72162-2497
Pioglitazole and metformin hydrochloride	Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1	TabletOral	Bryant Ranch Prepack	72162-2498
Pioglitazone and metformin hydrochloride	Metformin hydrochloride 500 mg/1; Pioglitazone hydrochloride 15 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-176
Pioglitazone and metformin hydrochloride	Metformin hydrochloride 850 mg/1; Pioglitazone hydrochloride 15 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-177
Pioglitazone and metformin hydrochloride	Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1	TabletOral	Bryant Ranch Prepack	71335-3020