Amgen, Inc
NDC labeler code: 55513
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
- Darbepoetin alfaAranesp · 14 products
- Adalimumab-attoAmjevita, Hyrimoz, Hadlima · 9 products
- Epoetin alfa-epbxRetacrit, Procrit, Epogen · 6 products
- Erenumab-aooeAimovig · 4 products
- FilgrastimNivestym, Releuko, Neupogen · 4 products
- RomiplostimNplate · 3 products
- IvabradineCorlanor · 3 products
- CinacalcetSensipar · 3 products
- SotorasibLumakras · 3 products
- EtelcalcetideParsabiv · 3 products
- ApremilastOtezla · 3 products
- Romosozumab-aqqgEvenity · 3 products
- Rituximab-arrxRiabni, Ruxience, Truxima · 2 products
- Talimogene laherparepvecImlygic · 2 products
- Pegfilgrastim-cbqvUdenyca, Stimufend, Neulasta · 2 products
- AfliberceptZaltrap, Pavblu, Eylea Hd · 2 products
- TrastuzumabOgivri, Kanjinti, Herzuma · 2 products
- Tezepelumab-ekkoTezspire · 2 products
- DenosumabBomyntra, Bildyos, Xtrenbo · 2 products
- Bevacizumab-bvzrZirabev, Jobevne, Vegzelma · 2 products
- PanitumumabVectibix · 2 products
- Eculizumab-aaghEpysqli, Soliris, Bkemv · 1 product
- InfliximabRemicade, Renflexis, Inflectra · 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 |
|---|---|---|---|
| August 29, 2025 | NDA210745 | Apremilast OTEZLA, OTEZLA XR | Amgen Inc |
| August 23, 2024 | BLA761298 | Aflibercept PAVBLU | Amgen Inc |
| May 28, 2024 | BLA761333 | Eculizumab-aagh BKEMV | Amgen Inc |
| December 17, 2021 | BLA761224 | Tezepelumab-ekko TEZSPIRE | Astrazeneca Ab |
| May 28, 2021 | NDA214665 | Sotorasib LUMAKRAS | Amgen Inc |
| December 17, 2020 | BLA761140 | Rituximab-arrx RIABNI | Amgen Inc |
| December 6, 2019 | BLA761086 | Infliximab AVSOLA | Amgen Inc |
| June 13, 2019 | BLA761073 | Trastuzumab KANJINTI | Amgen Inc |
| April 22, 2019 | NDA209964 | Ivabradine CORLANOR | Amgen Inc |
| April 9, 2019 | BLA761062 | Romosozumab-aqqg EVENITY | Amgen Inc |
| May 17, 2018 | BLA761077 | Erenumab-aooe AIMOVIG | Amgen Inc |
| September 14, 2017 | BLA761028 | Bevacizumab-bvzr MVASI | Amgen Inc |
| February 7, 2017 | NDA208325 | Etelcalcetide PARSABIV | Kai Pharms Inc |
| September 23, 2016 | BLA761024 | Adalimumab-atto AMJEVITA | Amgen Inc |
| April 15, 2015 | NDA206143 | Ivabradine CORLANOR | Amgen Inc |
| March 21, 2014 | NDA205437 | Apremilast OTEZLA | Amgen Inc |
| June 1, 2010 | BLA125320 | Denosumab PROLIA, XGEVA | Amgen |
| August 22, 2008 | BLA125268 | Romiplostim NPLATE | Amgen |
| September 27, 2006 | BLA125147 | Panitumumab VECTIBIX | Amgen |
| March 8, 2004 | NDA021688 | Cinacalcet SENSIPAR | Amgen |
| January 31, 2002 | BLA125031 | Pegfilgrastim-cbqv NEULASTA | Amgen |
| September 17, 2001 | BLA103951 | Darbepoetin alfa ARANESP | Amgen |
| February 20, 1991 | BLA103353 | Filgrastim NEUPOGEN | Amgen |
| June 1, 1989 | BLA103234 | Epoetin alfa-epbx EPOGEN/PROCRIT | Amgen |
| — | BLA125518 | Talimogene laherparepvec | — |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2026
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June 4, 2026 · Class II · Ongoing · D-0612-2026 · Ivabradine
Presence of Foreign Substance.
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.
-
June 4, 2026 · Class II · Ongoing · D-0615-2026 · Ivabradine
Presence of Foreign Substance.
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60
-
June 4, 2026 · Class II · Ongoing · D-0616-2026 · Cinacalcet
CGMP Deviations
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30
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June 4, 2026 · Class II · Ongoing · D-0614-2026 · Cinacalcet
CGMP Deviations
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30
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June 4, 2026 · Class II · Ongoing · D-0613-2026 · Cinacalcet
CGMP Deviations
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30
2025
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April 21, 2025 · Class II · Ongoing · D-0539-2025 · Romosozumab-aqqg
CGMP Deviations; potential temperature excursions due to transit delays
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
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April 21, 2025 · Class II · Ongoing · D-0538-2025 · Denosumab
CGMP Deviations; potential temperature excursions due to transit delays
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
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February 27, 2025 · Class II · Ongoing · D-0285-2025 · Filgrastim
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial
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February 27, 2025 · Class II · Ongoing · D-0286-2025 · Filgrastim
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC
2013
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September 17, 2013 · Class II · Terminated · D-66318-001 · Denosumab
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.
Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UP
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