What is NDC 50458-941?

50458-941 is the product NDC for Invokamet XR, Canagliflozin 50 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Invokamet XR (Canagliflozin and metformin hydrochloride).

What is the active ingredient?

Canagliflozin, Metformin hydrochloride.

Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Invokamet XR?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Invokamet XR NDC 50458-941 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50458-941Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50458-0941Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50458-941-01	5045809410150458094101	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-941-01)Marketed from Sep 20, 2016

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 XR
Generic name (nonproprietary): canagliflozin and metformin hydrochloride
Active ingredients: Canagliflozin — 50 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Janssen Pharmaceuticals, Inc.NDC labeler code 50458
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205879
Marketing start: Sep 20, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)P-Glycoprotein Inhibitors (Mechanism)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 50458-941_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

N450458094101 followed by a unit qualifier and the quantity

Package 50458-0941-01. 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 Aug 24, 2026. 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.

Full label on DailyMed (opens in a new tab)

About NDC 50458-941

What is NDC 50458-941?: 50458-941 is the product NDC for Invokamet XR, Canagliflozin 50 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Invokamet XR (Canagliflozin and metformin hydrochloride).
What is the active ingredient?: Canagliflozin, Metformin hydrochloride.
Who is the labeler?: Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Invokamet XR?: 3 other product NDCs are listed under this name. See all Invokamet XR NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Invokamet XR NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Invokamet XRcanagliflozin and metformin hydrochloride	Canagliflozin 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Janssen Pharmaceuticals, Inc.	50458-940	50458-0940-01
Invokamet XRcanagliflozin and metformin hydrochloride	Canagliflozin 150 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Janssen Pharmaceuticals, Inc.	50458-942	50458-0942-01
Invokamet XRcanagliflozin and metformin hydrochloride	Canagliflozin 150 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Janssen Pharmaceuticals, Inc.	50458-943	50458-0943-01

Other NDCs under NDA 205879

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 205879
Product	Strength	Form · route	Labeler	Product NDC
Invokamet XRcanagliflozin and metformin hydrochloride	Canagliflozin 50 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Janssen Pharmaceuticals, Inc.	50458-940
Invokamet XRcanagliflozin and metformin hydrochloride	Canagliflozin 150 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Janssen Pharmaceuticals, Inc.	50458-942
Invokamet XRcanagliflozin and metformin hydrochloride	Canagliflozin 150 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Janssen Pharmaceuticals, Inc.	50458-943