Janssen Pharmaceuticals, Inc.
NDC labeler code: 50458
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- RisperidoneUzedy, Risperdal, Risperdal M-Tab · 12 products
- Paliperidone palmitateErzofri Extended-Release, Invega Sustenna, Invega Trinza · 11 products
- Canagliflozin and metformin hydrochlorideInvokamet, Invokamet XR · 8 products
- TopiramateTopamax, Qudexy XR, Trokendi XR · 6 products
- RivaroxabanXarelto · 5 products
- PaliperidoneInvega · 4 products
- MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 4 products
- CanagliflozinInvokana · 2 products
- MebendazoleVermox · 1 product
- Pentosan polysulfate sodiumElmiron · 1 product
- ItraconazoleTolsura, Sporanox · 1 product
- PonesimodPonvory · 1 product
- Esketamine hydrochlorideSpravato · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| December 20, 2021 | NDA215859 | Rivaroxaban XARELTO | Janssen Pharms |
| March 18, 2021 | NDA213498 | Ponesimod PONVORY | Vanda Pharms Inc |
| March 5, 2019 | NDA211243 | Esketamine hydrochloride SPRAVATO | Janssen Pharms |
| October 19, 2016 | NDA208398 | Mebendazole VERMOX | Janssen Pharms |
| September 20, 2016 | NDA205879 | Canagliflozin and metformin hydrochloride INVOKAMET XR | Janssen Pharms |
| May 18, 2015 | NDA207946 | Paliperidone palmitate INVEGA HAFYERA, INVEGA TRINZA | Janssen Pharms |
| August 8, 2014 | NDA204353 | Canagliflozin and metformin hydrochloride INVOKAMET | Janssen Pharms |
| March 29, 2013 | NDA204042 | Canagliflozin INVOKANA | Janssen Pharms |
| July 1, 2011 | NDA022406 | Rivaroxaban XARELTO | Janssen Pharms |
| July 31, 2009 | NDA022264 | Paliperidone palmitate INVEGA SUSTENNA | Janssen Pharms |
| December 19, 2006 | NDA021999 | Paliperidone INVEGA | Janssen Pharms |
| April 2, 2003 | NDA021444 | Risperidone RISPERDAL | Janssen Pharms |
| August 1, 2000 | NDA021121 | Methylphenidate CONCERTA | Janssen Pharms |
| October 26, 1998 | NDA020844 | Topiramate TOPAMAX, TOPAMAX SPRINKLE | Janssen Pharms |
| December 24, 1996 | NDA020505 | Topiramate TOPAMAX | Janssen Pharms |
| September 26, 1996 | NDA020193 | Pentosan polysulfate sodium ELMIRON | Janssen Pharms |
| June 10, 1996 | NDA020588 | Risperidone RISPERDAL | Janssen Pharms |
| December 29, 1993 | NDA020272 | Risperidone RISPERDAL | Janssen Pharms |
| September 11, 1992 | NDA020083 | Itraconazole SPORANOX | Janssen Pharms |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2016
-
October 19, 2016 · Class III · Terminated · D-0115-2017 · Canagliflozin and metformin hydrochloride
Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titu
2014
-
September 17, 2014 · Class II · Terminated · D-0006-2015 · Rivaroxaban
Microbial Contamination of Non-Sterile Products: Consumer complaint confirmed microbial contamination in sales sample.
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026