Mylan Institutional Inc.
NDC labeler codes: 42292, 51079
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
- LevothyroxineTirosint, Tirosint Sol, Synthroid · 10 products
- AtorvastatinLipitor · 4 products
- Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 4 products
- Trifluoperazine hydrochloride4 products
- Haloperidol4 products
- ClozapineClozaril, Versacloz · 4 products
- Thioridazine hydrochloride4 products
- BuspironeBucapsol · 4 products
- DiazepamValium, Valtoco · 3 products
- Prazosin hydrochloride3 products
- AtenololTenormin · 3 products
- DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 3 products
- SpironolactoneAldactone · 3 products
- Hydralazine hydrochloride3 products
- MirtazapineRemeronsoltab, Remeron · 3 products
- AllopurinolAloprim · 2 products
- MetoprololToprol XL, Lopressor, Kapspargo · 2 products
- Divalproex sodiumDepakote, Depakote ER, Depakote Sprinkles · 2 products
- Carbidopa and levodopaCrexont, Rytary, Sinemet · 2 products
- Imatinib mesylateGleevec, Imkeldi · 2 products
- VoriconazoleVfend · 2 products
- MetoclopramideReglan, Gimoti · 2 products
- FenofibrateAntara, Lipofen, Tricor · 2 products
- Metolazone2 products
- Chlordiazepoxide hydrochloride2 products
- Verapamil hydrochloride1 product
- Loperamide hydrochloride1 product
- ValacyclovirValtrex · 1 product
- SucralfateCarafate · 1 product
- Midodrine hydrochloride1 product
- Spironolactone and hydrochlorothiazide1 product
- MethotrexateRasuvo, Otrexup, Trexall · 1 product
- LevetiracetamKeppra, Spritam, Keppra XR · 1 product
- Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 1 product
- LansoprazolePrevacid Solutab, Prevacid · 1 product
- ChlorthalidoneThalitone, Hemiclor · 1 product
- AbacavirZiagen · 1 product
- Isoniazid1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| June 21, 2017 | ANDA204644 | Imatinib mesylate IMATINIB MESYLATE | Mylan |
| September 15, 2015 | ANDA201824 | Clozapine CLOZAPINE | Mylan |
| December 7, 2012 | ANDA202856 | Fenofibrate FENOFIBRATE | Mylan Pharms Inc |
| June 18, 2012 | ANDA091294 | Abacavir ABACAVIR SULFATE | Mylan Pharms Inc |
| May 29, 2012 | ANDA091226 | Atorvastatin ATORVASTATIN CALCIUM | Mylan Pharms Inc |
| January 19, 2011 | ANDA090970 | Pantoprazole sodium PANTOPRAZOLE SODIUM | Mylan Pharms Inc |
| May 24, 2010 | ANDA078518 | Valacyclovir VALACYCLOVIR HYDROCHLORIDE | Mylan Pharms Inc |
| April 22, 2010 | ANDA090547 | Voriconazole VORICONAZOLE | Mylan Pharms Inc |
| November 10, 2009 | ANDA090763 | Lansoprazole LANSOPRAZOLE | Mylan Pharms Inc |
| January 29, 2009 | ANDA077567 | Divalproex sodium DIVALPROEX SODIUM | Mylan |
| November 4, 2008 | ANDA076919 | Levetiracetam LEVETIRACETAM | Mylan |
| January 16, 2004 | ANDA076704 | Metoprolol METOPROLOL TARTRATE | Mylan |
| December 23, 2003 | ANDA076698 | Metolazone METOLAZONE | Mylan |
| September 10, 2003 | ANDA076577 | Midodrine hydrochloride MIDODRINE HYDROCHLORIDE | Mylan Pharms Inc |
| June 19, 2003 | ANDA076122 | Mirtazapine MIRTAZAPINE | Mylan |
| June 5, 2002 | ANDA076187 | Levothyroxine LEVOTHYROXINE SODIUM | Mylan |
| August 20, 2001 | ANDA040424 | Spironolactone SPIRONOLACTONE | Mylan |
| June 28, 2001 | ANDA076008 | Buspirone BUSPIRONE HYDROCHLORIDE | Mylan |
| September 30, 1999 | ANDA075091 | Carbidopa and levodopa CARBIDOPA AND LEVODOPA | Mylan |
| May 27, 1999 | ANDA075417 | Clozapine CLOZAPINE | Mylan |
| April 20, 1999 | ANDA075138 | Verapamil hydrochloride VERAPAMIL HYDROCHLORIDE | Mylan |
| July 7, 1997 | ANDA040209 | Trifluoperazine hydrochloride TRIFLUOPERAZINE HYDROCHLORIDE | Mylan |
| May 2, 1997 | ANDA074910 | Diltiazem DILTIAZEM HYDROCHLORIDE | Mylan |
| March 29, 1996 | ANDA070848 | Sucralfate SUCRALFATE | Teva |
| June 15, 1993 | ANDA072801 | Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE | Teva |
Show the other 18 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 15, 1992 | ANDA081235 | Methotrexate METHOTREXATE SODIUM | Mylan |
| January 24, 1992 | ANDA073457 | Atenolol ATENOLOL | Mylan |
| September 18, 1991 | ANDA072741 | Loperamide hydrochloride LOPERAMIDE HYDROCHLORIDE | Mylan |
| February 28, 1989 | ANDA072575 | Prazosin hydrochloride PRAZOSIN HYDROCHLORIDE | Mylan |
| October 24, 1986 | ANDA018659 | Allopurinol ALLOPURINOL | Mylan |
| June 10, 1986 | ANDA070278 | Haloperidol HALOPERIDOL | Mylan |
| May 13, 1986 | ANDA070791 | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE | Mylan Pharms Inc |
| December 18, 1985 | ANDA089097 | Hydralazine hydrochloride HYDRALAZINE HYDROCHLORIDE | Pliva |
| September 4, 1985 | ANDA070325 | Diazepam DIAZEPAM | Mylan |
| July 29, 1985 | ANDA070184 | Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE | Teva |
| May 1, 1984 | ANDA088467 | Hydralazine hydrochloride HYDRALAZINE HYDROCHLORIDE | Pliva |
| May 1, 1984 | ANDA088468 | Hydralazine hydrochloride HYDRALAZINE HYDROCHLORIDE | Pliva |
| November 18, 1983 | ANDA088004 | Thioridazine hydrochloride THIORIDAZINE HYDROCHLORIDE | Mylan |
| February 26, 1981 | ANDA086831 | Chlorthalidone CHLORTHALIDONE | Mylan |
| August 3, 1979 | ANDA086513 | Spironolactone and hydrochlorothiazide SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | Mylan |
| June 10, 1976 | ANDA083116 | Chlordiazepoxide hydrochloride CHLORDIAZEPOXIDE HYDROCHLORIDE | Barr |
| June 10, 1976 | ANDA084769 | Chlordiazepoxide hydrochloride CHLORDIAZEPOXIDE HYDROCHLORIDE | Barr |
| August 24, 1972 | ANDA080937 | Isoniazid ISONIAZID | Genus Lifesciences |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
November 19, 2024 · Class II · Ongoing · D-0136-2025 · Levothyroxine
Subpotent and Superpotent Drug
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-0
-
November 19, 2024 · Class II · Ongoing · D-0132-2025 · Levothyroxine
Subpotent and Superpotent Drug
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-0
-
November 19, 2024 · Class II · Ongoing · D-0134-2025 · Levothyroxine
Subpotent and Superpotent Drug
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-0
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
- All drug companiesA to Z
- 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