AstraZeneca Pharmaceuticals LP
NDC labeler codes: 0186, 0310
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
- QuetiapineSeroquel, Seroquel XR · 10 products
- EsomeprazoleNexium · 7 products
- Dapagliflozin and metformin hydrochlorideXigduo XR · 5 products
- OlaparibLynparza · 4 products
- Budesonide and formoterol fumarate dihydrateSymbicort, Breyna · 4 products
- SelumetinibKoselugo · 4 products
- OsimertinibTagrisso · 4 products
- RosuvastatinCrestor · 4 products
- BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 3 products
- AcalabrutinibCalquence · 3 products
- BenralizumabFasenra · 3 products
- TicagrelorBrilinta · 2 products
- Anifrolumab-fniaSaphnelo · 2 products
- BaxdrostatBaxfendy · 2 products
- Pramlintide acetateSymlinpen · 2 products
- TremelimumabImjudo · 2 products
- DapagliflozinFarxiga · 2 products
- RoflumilastZoryve, Daliresp · 2 products
- EplontersenWainua · 2 products
- CapivasertibTruqap · 2 products
- Sodium zirconium cyclosilicateLokelma · 2 products
- Budesonide, glycopyrrolate, and formoterol fumarateBreztri · 2 products
- ExenatideByetta · 2 products
- DurvalumabImfinzi · 2 products
- Glycopyrrolate and formoterol fumarateBevespi Aerosphere · 1 product
- Albuterol sulfate and budesonideAirsupra · 1 product
- GefitinibIressa · 1 product
- FulvestrantCligavyx, Faslodex · 1 product
- Andexanet alfaAndexxa · 1 product
- CamizestrantEtcamah · 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 |
|---|---|---|---|
| September 4, 2026 | NDA220359 | Camizestrant ETCAMAH | Astrazeneca |
| May 15, 2026 | NDA219878 | Baxdrostat BAXFENDY | Astrazeneca Ab |
| April 24, 2026 | BLA761451 | Anifrolumab-fnia SAPHNELO | Astrazeneca Ab |
| September 10, 2025 | NDA219943 | Selumetinib KOSELUGO | Astrazeneca |
| December 21, 2023 | NDA217388 | Eplontersen WAINUA, WAINUA (AUTOINJECTOR) | Astrazeneca Ab |
| November 16, 2023 | NDA218197 | Capivasertib TRUQAP | Astrazeneca |
| January 10, 2023 | NDA214070 | Albuterol sulfate and budesonide AIRSUPRA | Astrazeneca |
| October 21, 2022 | BLA761289 | Tremelimumab IMJUDO | Astrazeneca Ab |
| August 3, 2022 | NDA216387 | Acalabrutinib CALQUENCE | Astrazeneca |
| July 30, 2021 | BLA761123 | Anifrolumab-fnia SAPHNELO | Astrazeneca Ab |
| July 23, 2020 | NDA212122 | Budesonide, glycopyrrolate, and formoterol fumarate BREZTRI AEROSPHERE | Astrazeneca Ab |
| April 10, 2020 | NDA213756 | Selumetinib KOSELUGO | Astrazeneca |
| May 18, 2018 | NDA207078 | Sodium zirconium cyclosilicate LOKELMA | Astrazeneca |
| November 14, 2017 | BLA761070 | Benralizumab FASENRA | Astrazeneca Ab |
| October 31, 2017 | NDA210259 | Acalabrutinib CALQUENCE | Astrazeneca |
| August 17, 2017 | NDA208558 | Olaparib LYNPARZA | Astrazeneca |
| May 1, 2017 | BLA761069 | Durvalumab IMFINZI | Astrazeneca Uk Ltd |
| April 25, 2016 | NDA208294 | Glycopyrrolate and formoterol fumarate BEVESPI AEROSPHERE | Astrazeneca |
| November 13, 2015 | NDA208065 | Osimertinib TAGRISSO | Astrazeneca |
| July 13, 2015 | NDA206995 | Gefitinib IRESSA | Astrazeneca |
| October 29, 2014 | NDA205649 | Dapagliflozin and metformin hydrochloride XIGDUO XR | Astrazeneca Ab |
| January 8, 2014 | NDA202293 | Dapagliflozin FARXIGA | Astrazeneca Ab |
| July 20, 2011 | NDA022433 | Ticagrelor BRILINTA | Astrazeneca |
| February 28, 2011 | NDA022522 | Roflumilast DALIRESP | Astrazeneca |
| February 27, 2008 | NDA022101 | Esomeprazole NEXIUM | Astrazeneca |
Show the other 11 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| May 17, 2007 | NDA022047 | Quetiapine SEROQUEL XR | Cheplapharm |
| October 20, 2006 | NDA021957 | Esomeprazole NEXIUM | Astrazeneca |
| July 21, 2006 | NDA021929 | Budesonide and formoterol fumarate dihydrate SYMBICORT | Astrazeneca |
| April 28, 2005 | NDA021773 | Exenatide BYETTA | Astrazeneca Ab |
| March 16, 2005 | NDA021332 | Pramlintide acetate SYMLIN | Astrazeneca Ab |
| August 12, 2003 | NDA021366 | Rosuvastatin CRESTOR | Astrazeneca |
| April 25, 2002 | NDA021344 | Fulvestrant FASLODEX | Astrazeneca |
| February 20, 2001 | NDA021153 | Esomeprazole NEXIUM | Astrazeneca |
| August 8, 2000 | NDA020929 | Budesonide PULMICORT RESPULES | Astrazeneca |
| September 26, 1997 | NDA020639 | Quetiapine SEROQUEL | Cheplapharm |
| — | BLA125586 | Andexanet alfa | — |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
-
October 8, 2025 · Class II · Ongoing · D-0028-2026 · Benralizumab
Lack of Assurance of Sterility:
Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. NDC 0310-1730-30
-
May 14, 2025 · Class II · Ongoing · D-0444-2025 · Albuterol sulfate and budesonide
Defective delivery system
Airsupra (albuterol and budesonide) inhalation aerosol, 90 mcg/80 mcg per inhalation, packaged in a) 120-inhalation canister (NDC 0310-9080-12) b) 28-inhalation canister (NDC 0310-9080-28), Rx only, Manufactured for: Ast
2021
-
March 15, 2021 · Class II · Terminated · D-0434-2021 · Glycopyrrolate and formoterol fumarate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharmaceuticals, LP, Wilm
-
March 15, 2021 · Class II · Terminated · D-0436-2021 · Dapagliflozin and metformin hydrochloride
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850
-
March 15, 2021 · Class II · Terminated · D-0433-2021 · Ticagrelor
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850
-
March 15, 2021 · Class II · Terminated · D-0435-2021 · Dapagliflozin and metformin hydrochloride
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squib
-
March 15, 2021 · Class II · Terminated · D-0561-2021 · Budesonide and formoterol fumarate dihydrate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120 inhalations Rx only Manufactured for: AstraZeneca Pharmaceuticals LP,
2017
-
May 25, 2017 · Class I · Terminated · D-0958-2017 · Ticagrelor
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08.
2013
-
January 11, 2013 · Class III · Terminated · D-198-2013 · Budesonide
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
-
January 11, 2013 · Class III · Terminated · D-199-2013 · Budesonide
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
Show the 1 older recalls
2012
-
July 2, 2012 · Class III · Terminated · D-1410-2012 · Esomeprazole
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC
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