Trigen Laboratories, LLC
NDC labeler code: 13811
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
- MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 7 products
- EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 5 products
- Hydromorphone hydrochlorideDilaudid · 4 products
- Tramadol hydrochlorideConzip · 3 products
- Venlafaxine hydrochlorideEffexor XR · 1 product
- LacosamideVimpat, Motpoly XR · 1 product
- Nitrofurantoin (monohydrate/macrocrystals)Macrobid, Nitrofurantoin Monohydrate Macrocrystalline, Nitrofurantoin Mono · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| November 14, 2024 | ANDA218464 | Lacosamide LACOSAMIDE | Acella |
| June 23, 2022 | NDA216117 | Methylphenidate RELEXXII | Osmotica Pharm Us |
| May 24, 2018 | ANDA208516 | Nitrofurantoin (monohydrate/macrocrystals) NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | Sunny |
| July 28, 2017 | ANDA205327 | Methylphenidate METHYLPHENIDATE HYDROCHLORIDE | Osmotica Pharm Us |
| July 7, 2016 | ANDA205629 | Hydromorphone hydrochloride HYDROMORPHONE HYDROCHLORIDE | Osmotica Pharm Us |
| May 7, 2010 | NDA022370 | Tramadol hydrochloride CONZIP | Cipher Pharms Inc |
| May 20, 2008 | NDA022104 | Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE | Osmotica Pharm Us |
| June 4, 2007 | NDA022038 | Estradiol DIVIGEL | Vertical Pharms |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
June 17, 2024 · Class II · Terminated · D-0579-2024 · Methylphenidate
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
2018
-
February 28, 2018 · Class III · Terminated · D-0581-2018 · Methylphenidate
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
2017
-
December 18, 2017 · Class III · Terminated · D-0110-2018 · Methylphenidate
Subpotent Drug
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10
-
December 18, 2017 · Class III · Terminated · D-0111-2018 · Methylphenidate
Subpotent Drug
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
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