Prescription drug · NDA
Duetact (Pioglitazone and glimepiride) NDC 64764-304
Pioglitazone hydrochloride 30 mg/1; Glimepiride 4 mg/1 · Tablet · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-304-30 | 6476403043064764030430 | 30 TABLET in 1 BOTTLE (64764-304-30)Marketed from Jul 28, 2006 | |
| 64764-304-90 | 6476403049064764030490 | 90 TABLET in 1 BOTTLE (64764-304-90)Marketed from Jul 28, 2006 |
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)
- Duetact
- Generic name (nonproprietary)
- pioglitazone and glimepiride
- Active ingredients
- Pioglitazone hydrochloride — 30 mg/1Glimepiride — 4 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 64764
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021925
- Marketing start
- Listing expires
- Other FDA classes
- Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)Peroxisome Proliferator-activated Receptor gamma Agonists (Mechanism)Sulfonylurea Compounds (Chemical structure)Thiazolidinediones (Chemical structure)
- Identifiers
- Product ID 64764-304_23f68487-5d22-4618-9ccc-417aeb9fd3a8SPL ID 23f68487-5d22-4618-9ccc-417aeb9fd3a8SPL set ID f8b0c917-3fdd-4a28-a47d-6225b8195458RxCUI 647237, 647239, 731457, 731463UNII JQT35NPK6C, 6KY687524KUPC 0364764302306, 0364764304300
- Pharmacologic class
- Peroxisome Proliferator Receptor alpha Agonist; Peroxisome Proliferator Receptor gamma Agonist; Sulfonylurea; 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
N464764030430followed by a unit qualifier and the quantityPackage 64764-0304-30. 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)
DUETACT is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a thiazolidinedione and sulfonylurea or who have inadequate glycemic control on a thiazolidinedione alone or a sulfonylurea alone [see Clinical Studies ( 14 )] . Important Limitations of Use Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin. DUETACT 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 ( 5.5 )] . DUETACT is a thiazolidinedione and a sulfonylurea com…
Excerpt only. Read the full label for complete information.
About NDC 64764-304
- What is NDC 64764-304?
- 64764-304 is the product NDC for Duetact, Pioglitazone hydrochloride 30 mg/1; Glimepiride 4 mg/1 tablet, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Duetact (Pioglitazone and glimepiride).
- What is the active ingredient?
- Pioglitazone hydrochloride, Glimepiride.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 64764. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Duetact?
- 1 other product NDC are listed under this name. See all Duetact NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Duetact products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Duetactpioglitazone and glimepiride | Pioglitazone hydrochloride 30 mg/1; Glimepiride 2 mg/1 | TabletOral | Takeda Pharmaceuticals America, Inc. | 64764-302 | 64764-0302-3064764-0302-90 |
Other NDCs under NDA 021925
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 |
|---|---|---|---|---|
| Duetactpioglitazone and glimepiride | Pioglitazone hydrochloride 30 mg/1; Glimepiride 2 mg/1 | TabletOral | Takeda Pharmaceuticals America, Inc. | 64764-302 |
| pioglitazone and glimepiride | Pioglitazone hydrochloride 30 mg/1; Glimepiride 2 mg/1 | TabletOral | Prasco Laboratories | 66993-821 |
| pioglitazone and glimepiride | Pioglitazone hydrochloride 30 mg/1; Glimepiride 4 mg/1 | TabletOral | Prasco Laboratories | 66993-822 |