Prescription drug · NDA
Invokamet NDC 50458-542
canagliflozin and metformin hydrochloride · Canagliflozin 150 mg/1; Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-542-60 | 50458054260 | 60 TABLET, FILM COATED in 1 BOTTLE (50458-542-60)Marketed from Aug 8, 2014 |
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)
- Invokamet
- Generic name (nonproprietary)
- canagliflozin and metformin hydrochloride
- Active ingredients
- Canagliflozin — 150 mg/1Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204353
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)P-Glycoprotein Inhibitors (Mechanism)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 50458-542_95b8c81c-dfe3-4dd4-be06-8dd1d935f07eSPL ID 95b8c81c-dfe3-4dd4-be06-8dd1d935f07eSPL set ID 6868666b-c25e-40d1-9d1f-306bbe9390c1RxCUI 1545150, 1545156, 1545157, 1545159, 1545161, 1545163, 1545164, 1545166, 1810997, 1810999, 1811002, 1811003, 1811006, 1811007, 1811010, 1811011UNII 786Z46389E, 0SAC974Z85UPC 0350458543605, 0350458541601
- Pharmacologic class
- Biguanide; Sodium-Glucose Cotransporter 2 Inhibitor
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
N450458054260followed by a unit qualifier and the quantityPackage 50458-0542-60. 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)
INVOKAMET INVOKAMET is a combination of canagliflozin and metformin HCl immediate-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. INVOKAMET XR INVOKAMET XR is a combination of canagliflozin and metformin HCl extended-release indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Canagliflozin Canagliflozin, when used as a component of INVOKAMET or INVOKAMET XR, is indicated in adults with type 2 diabetes mellitus to reduce the risk of: Major adverse cardiovascular even…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204353
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 |
|---|---|---|---|---|
| Invokametcanagliflozin and metformin hydrochloride | Canagliflozin 150 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-543 |
| Invokametcanagliflozin and metformin hydrochloride | Canagliflozin 50 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-540 |
| Invokametcanagliflozin and metformin hydrochloride | Canagliflozin 50 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-541 |