Prescription drug · ANDA
Pioglitazone Hydrochloride and Metformin Hydrochloride NDC 65862-526
Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-526-18 | 6586205261865862052618 | 180 TABLET, FILM COATED in 1 BOTTLE (65862-526-18)Marketed from Feb 13, 2013 | |
| 65862-526-60 | 6586205266065862052660 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-526-60)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
- Aurobindo Pharma LimitedNDC labeler code 65862
- 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 65862-526_98930be0-b506-4a8c-8b1a-90117ac500c3SPL ID 98930be0-b506-4a8c-8b1a-90117ac500c3SPL set ID 1fa2703e-fb73-44d5-aaa2-b12b1090d42cRxCUI 861783, 861822UNII 786Z46389E, JQT35NPK6C
- 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
N465862052618followed by a unit qualifier and the quantityPackage 65862-0526-18. 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.
About NDC 65862-526
- What is NDC 65862-526?
- 65862-526 is the product NDC for Pioglitazone Hydrochloride and Metformin Hydrochloride, Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pioglitazone Hydrochloride and Metformin Hydrochloride.
- What is the active ingredient?
- Pioglitazone hydrochloride, Metformin hydrochloride.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pioglitazone Hydrochloride and Metformin Hydrochloride?
- 2 other product NDCs are listed under this name. See all Pioglitazone Hydrochloride 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 Pioglitazone Hydrochloride 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) |
|---|---|---|---|---|---|
| Pioglitazone Hydrochloride and Metformin Hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-217 | 57237-0217-6057237-0217-81 |
| Pioglitazone Hydrochloride and Metformin Hydrochloride | Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-218 | 57237-0218-6057237-0218-81 |
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 | Rising Pharma Holdings, Inc. | 57237-218 |