Prescription drug · NDA
Invokana (canagliflozin) NDC 50458-141
Canagliflozin 300 mg/1 · Tablet, Film coated · Oral · Janssen Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50458-141-01 | 50458014101 | 5 TABLET, FILM COATED in 1 BOTTLE (50458-141-01)Marketed from Mar 29, 2013 · Sample package | |
| 50458-141-10 | 50458014110 | 10 BLISTER PACK in 1 CARTON (50458-141-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Mar 29, 2013 | |
| 50458-141-30 | 50458014130 | 30 TABLET, FILM COATED in 1 BOTTLE (50458-141-30)Marketed from Mar 29, 2013 | |
| 50458-141-50 | 50458014150 | 500 TABLET, FILM COATED in 1 BOTTLE (50458-141-50)Marketed from Mar 29, 2013 | |
| 50458-141-90 | 50458014190 | 90 TABLET, FILM COATED in 1 BOTTLE (50458-141-90)Marketed from Mar 29, 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)
- Invokana
- Generic name (nonproprietary)
- canagliflozin
- Active ingredients
- Canagliflozin — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 204042
- Marketing start
- Listing expires
- Other FDA classes
- P-Glycoprotein Inhibitors (Mechanism)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 50458-141_cb98e349-535b-44ab-875f-f6d84382c49bSPL ID cb98e349-535b-44ab-875f-f6d84382c49bSPL set ID b9057d3b-b104-4f09-8a61-c61ef9d4a3f3RxCUI 1373463, 1373469, 1373471, 1373473UNII 0SAC974Z85UPC 0350458141900, 0350458140903
- Pharmacologic class
- 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
N450458014101followed by a unit qualifier and the quantityPackage 50458-0141-01. 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 .
Indications (excerpt from the label)
INVOKANA (canagliflozin) is 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. to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease (CVD). to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria greater than 300 mg/day. INVOKANA is a sodium-glucose co-tr…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 204042
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 |
|---|---|---|---|---|
| Invokanacanagliflozin | Canagliflozin 100 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-140 |
| Invokanacanagliflozin | Canagliflozin 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1425 |
| Invokanacanagliflozin | Canagliflozin 300 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1426 |
| Invokanacanagliflozin | Canagliflozin 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5034 |
| Invokanacanagliflozin | Canagliflozin 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5029 |
| Invokanacanagliflozin | Canagliflozin 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4364 |