Prescription drug · ANDA
Pioglitazone Hydrochloride and Metformin Hydrochloride NDC 57237-218
Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-218-60 | 57237021860 | 60 TABLET, FILM COATED in 1 BOTTLE (57237-218-60)Marketed from Feb 13, 2013 | |
| 57237-218-81 | 57237021881 | 180 TABLET, FILM COATED in 1 BOTTLE (57237-218-81)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 — 850 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
- 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 57237-218_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
N457237021860followed by a unit qualifier and the quantityPackage 57237-0218-60. 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 . 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.
Other NDCs under ANDA 200823
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 |
|---|---|---|---|---|
| Pioglitazone Hydrochloride and Metformin Hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-217 |
| 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 |