Prescription drug · NDA
Actoplus Met NDC 64764-158
pioglitazone and metformin hydrochloride · Pioglitazone hydrochloride 15 mg/1; Metformin hydrochloride 850 mg/1 · Tablet, Film coated · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-158-18 | 64764015818 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-18)Marketed from Aug 29, 2005 | |
| 64764-158-41 | 64764015841 | 4 CARTON in 1 TRAY (64764-158-41) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 29, 2005 | |
| 64764-158-60 | 64764015860 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-60)Marketed from Aug 29, 2005 |
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)
- Actoplus Met
- Generic name (nonproprietary)
- pioglitazone and metformin hydrochloride
- Active ingredients
- Pioglitazone hydrochloride — 15 mg/1Metformin hydrochloride — 850 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021842
- 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 64764-158_8bacb433-92b6-4285-9ed3-b49e46ec63fcSPL ID 8bacb433-92b6-4285-9ed3-b49e46ec63fcSPL set ID 42e49120-6f3f-11db-9fe1-0800200c9a66RxCUI 861822, 861824UNII JQT35NPK6C, 786Z46389EUPC 0364764158606
- 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
N464764015818followed by a unit qualifier and the quantityPackage 64764-0158-18. 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)
ACTOPLUS MET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ACTOPLUS MET is not recommended to treat type 1 diabetes mellitus or diabetic ketoacidosis. ACTOPLUS MET is a combination of pioglitazone, a thiazolidinedione agonist of peroxisome proliferator receptor gamma, and metformin hydrochloride (HCl), 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 or diabetic ketoacidosis. ( 1 )
Excerpt only. Read the full label for complete information.