Prescription drug · NDA
Actos (pioglitazone) NDC 64764-301
Pioglitazone hydrochloride 30 mg/1 · Tablet · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-301-02 | 64764030102 | 6 CARTON in 1 TRAY (64764-301-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACKMarketed from Jul 15, 1999 | |
| 64764-301-14 | 64764030114 | 30 TABLET in 1 BOTTLE (64764-301-14)Marketed from Jul 15, 1999 | |
| 64764-301-15 | 64764030115 | 90 TABLET in 1 BOTTLE (64764-301-15)Marketed from Jul 15, 1999 | |
| 64764-301-16 | 64764030116 | 500 TABLET in 1 BOTTLE (64764-301-16)Marketed from Jul 15, 1999 |
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)
- Actos
- Generic name (nonproprietary)
- pioglitazone
- Active ingredients
- Pioglitazone hydrochloride — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021073
- Marketing start
- Listing expires
- Other FDA classes
- Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Thiazolidinediones (Chemical structure)
- Identifiers
- Product ID 64764-301_20e43dff-4bf2-4ae7-82a1-e7e895123f93SPL ID 20e43dff-4bf2-4ae7-82a1-e7e895123f93SPL set ID d2ddc491-88a9-4063-9150-443b4fa4330cRxCUI 261266, 261267, 261268, 312440, 312441, 317573UNII JQT35NPK6CUPC 0364764451240, 0364764151041, 0364764301149
- Pharmacologic class
- 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
N464764030102followed by a unit qualifier and the quantityPackage 64764-0301-02. 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)
Monotherapy and Combination Therapy ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14) ] . Important Limitations of Use ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOS should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3) ] . ACTOS is a thiazolidinedione and an agonist for peroxisome proliferator-activated receptor (PPAR) gamma indicated as an adjunct to diet and exercise to improve…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021073
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 |
|---|---|---|---|---|
| Actospioglitazone | Pioglitazone hydrochloride 15 mg/1 | TabletOral | Takeda Pharmaceuticals America, Inc. | 64764-151 |
| Actospioglitazone | Pioglitazone hydrochloride 45 mg/1 | TabletOral | Takeda Pharmaceuticals America, Inc. | 64764-451 |