Prescription drug · ANDA
Pioglitazole and metformin hydrochloride NDC 72162-2497
Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2497-2 | 7216224970272162249702 | 180 TABLET in 1 BOTTLE (72162-2497-2)Marketed from May 15, 2025 | |
| 72162-2497-6 | 7216224970672162249706 | 60 TABLET in 1 BOTTLE (72162-2497-6)Marketed from May 15, 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)
- Pioglitazole and metformin hydrochloride
- Generic name (nonproprietary)
- pioglitazole and metformin hydrochloride
- Active ingredients
- Pioglitazone hydrochloride — 15 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 72162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204802
- Marketing start
- Listing expires
- 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 72162-2497_3531b9e4-c26d-e9a3-e063-6394a90a2c48SPL ID 3531b9e4-c26d-e9a3-e063-6394a90a2c48SPL set ID 7418254e-7232-466f-9d6b-4743b0bba2a1RxCUI 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
N472162249702followed by a unit qualifier and the quantityPackage 72162-2497-02. 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 . 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.
About NDC 72162-2497
- What is NDC 72162-2497?
- 72162-2497 is the product NDC for Pioglitazole and metformin hydrochloride, Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pioglitazole and metformin hydrochloride.
- What is the active ingredient?
- Pioglitazone hydrochloride, Metformin hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 72162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pioglitazole and metformin hydrochloride?
- 1 other product NDC are listed under this name. See all Pioglitazole and metformin hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pioglitazole and metformin hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pioglitazole and metformin hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2498 | 72162-2498-0272162-2498-06 |
Other NDCs under ANDA 204802
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 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 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3019 |
| Pioglitazone and metformin hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3020 |