Prescription drug · NDA
Invokana (Canagliflozin) NDC 50090-5034
Canagliflozin 100 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5034-0 | 5009050340050090503400 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5034-0)Marketed from May 4, 2020 | |
| 50090-5034-1 | 5009050340150090503401 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5034-1)Marketed from May 5, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-5034_f8148180-4b45-4670-a46c-94171161f367SPL ID f8148180-4b45-4670-a46c-94171161f367SPL set ID 8d5f892b-e4f3-4a9e-9a91-95e2fca34144RxCUI 1373463, 1373469UNII 0SAC974Z85
- 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
N450090503400followed by a unit qualifier and the quantityPackage 50090-5034-00. 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 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-transporter 2 (SGLT2) inhibitor indicated: As an …
Excerpt only. Read the full label for complete information.
About NDC 50090-5034
- What is NDC 50090-5034?
- 50090-5034 is the product NDC for Invokana (canagliflozin), Canagliflozin 100 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Invokana (Canagliflozin).
- What is the active ingredient?
- Canagliflozin.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Invokana?
- 6 other product NDCs are listed under this name. See all Invokana NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Invokana products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Invokanacanagliflozin | Canagliflozin 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4364 | 50090-4364-00 |
| Invokanacanagliflozin | Canagliflozin 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5029 | 50090-5029-00 |
| Invokanacanagliflozin | Canagliflozin 100 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-140 | 50458-0140-0150458-0140-1050458-0140-30+2 more |
| Invokanacanagliflozin | Canagliflozin 300 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-141 | 50458-0141-0150458-0141-1050458-0141-30+2 more |
| Invokanacanagliflozin | Canagliflozin 100 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1425 | 55154-1425-08 |
| Invokanacanagliflozin | Canagliflozin 300 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-1426 | 55154-1426-08 |
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 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4364 |
| Invokanacanagliflozin | Canagliflozin 300 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5029 |
| Invokanacanagliflozin | Canagliflozin 100 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-140 |
| Invokanacanagliflozin | Canagliflozin 300 mg/1 | Tablet, Film coatedOral | Janssen Pharmaceuticals, Inc. | 50458-141 |
| 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 |