GlaxoSmithKline LLC
NDC labeler codes: 0173, 49401, 81864
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
- LamotrigineLamictal, Lamictal XR, Subvenite · 17 products
- SumatriptanImitrex, Tosymra, Zembrace Symtouch · 6 products
- Fluticasone propionate and salmeterolFluticasone Propionate and Salmeterol Diskus, Advair Diskus, Advair HFA · 6 products
- DaprodustatJesduvroq · 5 products
- BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 3 products
- Fluticasone furoate and vilanterol trifenatateBreo Ellipta · 3 products
- Fluticasone furoateArnuity Ellipta, Fluticasone Furoate Ellipta · 3 products
- BelimumabBenlysta · 3 products
- MepolizumabNucala · 3 products
- NiraparibZejula · 3 products
- MomelotinibOjjaara · 3 products
- AtovaquoneMepron · 2 products
- ValacyclovirValtrex · 2 products
- Fluticasone furoate, umeclidinium bromide and vilanterol trifenatateTrelegy Ellipta · 2 products
- Atovaquone and proguanil hydrochlorideMalarone · 2 products
- ZanamivirRelenza · 1 product
- Umeclidinium bromide and vilanterol trifenatateAnoro Ellipta, Umeclidinium and Vilanterol Ellipta · 1 product
- Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 1 product
- TafenoquineArakoda, Krintafel · 1 product
- DostarlimabJemperli · 1 product
- Salmeterol xinafoateSerevent Diskus · 1 product
- Tebipenem pivoxilUtebzi · 1 product
- GepotidacinBlujepa · 1 product
- Belantamab mafodotinBlenrep · 1 product
- DepemokimabExdensur · 1 product
- UmeclidiniumUmeclidinium Ellipta, Incruse Ellipta · 1 product
- BepirovirsenHibsago · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| October 20, 2026 | NDA221276 | Bepirovirsen HIBSAGO | Glaxosmithkline LLC |
| June 17, 2026 | NDA215960 | Tebipenem pivoxil UTEBZI | Glaxosmithkline |
| December 16, 2025 | BLA761458 | Depemokimab EXDENSUR | Glaxosmithkline LLC |
| October 23, 2025 | BLA761440 | Belantamab mafodotin BLENREP | Glaxosmithkline LLC |
| March 25, 2025 | NDA218230 | Gepotidacin BLUJEPA | Glaxosmithkline |
| September 15, 2023 | NDA216873 | Momelotinib OJJAARA | Glaxosmithkline |
| April 26, 2023 | NDA214876 | Niraparib ZEJULA | Glaxosmithkline |
| February 1, 2023 | NDA216951 | Daprodustat JESDUVROQ | Glaxosmithkline |
| April 22, 2021 | BLA761174 | Dostarlimab JEMPERLI | Glaxosmithkline |
| June 6, 2019 | BLA761122 | Mepolizumab NUCALA | Glaxosmithkline |
| July 20, 2018 | NDA210795 | Tafenoquine KRINTAFEL | Glaxosmithkline |
| September 18, 2017 | NDA209482 | Fluticasone furoate, umeclidinium bromide and vilanterol trifenatate TRELEGY ELLIPTA | Glaxosmithkline |
| July 20, 2017 | BLA761043 | Belimumab BENLYSTA | Glaxosmithkline LLC |
| November 4, 2015 | BLA125526 | Mepolizumab NUCALA | Glaxosmithkline LLC |
| August 20, 2014 | NDA205625 | Fluticasone furoate ARNUITY ELLIPTA | Glaxosmithkline |
| April 30, 2014 | NDA205382 | Umeclidinium INCRUSE ELLIPTA | Glaxo Grp England |
| December 18, 2013 | NDA203975 | Umeclidinium bromide and vilanterol trifenatate ANORO ELLIPTA | Glaxosmithkline |
| May 10, 2013 | NDA204275 | Fluticasone furoate and vilanterol trifenatate BREO ELLIPTA | Glaxo Grp Ltd |
| March 9, 2011 | BLA125370 | Belimumab BENLYSTA | Human Genome Sciences Inc. |
| May 29, 2009 | NDA022115 | Lamotrigine LAMICTAL XR | Glaxosmithkline LLC |
| May 8, 2009 | NDA022251 | Lamotrigine LAMICTAL ODT | Glaxosmithkline LLC |
| June 8, 2006 | NDA021254 | Fluticasone propionate and salmeterol ADVAIR HFA | Glaxo Grp Ltd |
| April 19, 2001 | NDA020983 | Albuterol sulfate VENTOLIN HFA | Glaxosmithkline |
| August 24, 2000 | NDA021077 | Fluticasone propionate and salmeterol ADVAIR DISKUS 100/50, ADVAIR DISKUS 250/50, ADVAIR DISKUS 500/50 | Glaxo Grp Ltd |
| July 14, 2000 | NDA021078 | Atovaquone and proguanil hydrochloride MALARONE, MALARONE PEDIATRIC | Glaxosmithkline |
Show the other 9 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| July 26, 1999 | NDA021036 | Zanamivir RELENZA | Glaxosmithkline |
| August 24, 1998 | NDA020764 | Lamotrigine LAMICTAL CD | Glaxosmithkline LLC |
| September 19, 1997 | NDA020692 | Salmeterol xinafoate SEREVENT | Glaxosmithkline |
| October 4, 1996 | NDA020358 | Bupropion WELLBUTRIN SR | Glaxosmithkline |
| June 23, 1995 | NDA020487 | Valacyclovir VALTREX | Glaxosmithkline |
| June 1, 1995 | NDA020132 | Sumatriptan IMITREX | Glaxosmithkline |
| February 8, 1995 | NDA020500 | Atovaquone MEPRON | Glaxosmithkline LLC |
| December 27, 1994 | NDA020241 | Lamotrigine LAMICTAL | Glaxosmithkline LLC |
| December 28, 1992 | NDA020080 | Sumatriptan IMITREX, IMITREX STATDOSE (AUTOINJECTOR) | Glaxosmithkline |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
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April 21, 2025 · Class II · Ongoing · D-0540-2025 · Belimumab
CGMP Deviations; potential temperature excursions due to transit delays
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
2023
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December 12, 2023 · Class III · Terminated · D-0160-2024 · Umeclidinium bromide and vilanterol trifenatate
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10
2021
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March 15, 2021 · Class II · Terminated · D-0480-2021 · Fluticasone furoate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709
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March 15, 2021 · Class II · Terminated · D-0482-2021 · Fluticasone furoate, umeclidinium bromide and vilanterol trifenatate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research T
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March 15, 2021 · Class II · Terminated · D-0481-2021 · Fluticasone furoate, umeclidinium bromide and vilanterol trifenatate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
2019
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September 6, 2019 · Class II · Terminated · D-1876-2019 · Mepolizumab
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle
2017
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May 16, 2017 · Class II · Ongoing · D-0793-2017 · Albuterol sulfate
Defective Delivery System: Elevated number of units with out of specification results for leak rate
Ventolin HFA (albuterol sulfate) Inhalation, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20.
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March 22, 2017 · Class II · Ongoing · D-0626-2017 · Albuterol sulfate
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
2015
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December 3, 2015 · Class II · Terminated · D-0519-2016 · Albuterol sulfate
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20
2013
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November 6, 2013 · Class II · Terminated · D-387-2014 · Sumatriptan
Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield.
Imitrex STATdose System, Imitrex (sumatriptan succinate) Injection, 2 prefilled 0.5 mL syringe cartridges each containing 6 mg of sumatriptan for subcutaneous injection only, 1 imitrex STATdose Pen, 1 carrying case, Rx o
Show the 3 older recalls
2012
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October 24, 2012 · Class III · Terminated · D-065-2013 · Fluticasone propionate and salmeterol
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.
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October 24, 2012 · Class III · Terminated · D-064-2013 · Fluticasone propionate and salmeterol
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27
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July 26, 2012 · Class II · Terminated · D-1666-2012 · Albuterol sulfate
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
Ventolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Tri
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
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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