E.R. Squibb & Sons, L.L.C.
NDC labeler code: 0003
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
- DasatinibSprycel, Phyrago · 6 products
- NivolumabOpdivo · 4 products
- ApixabanEliquis, Eliquis Sprinkle · 4 products
- AbataceptOrencia · 4 products
- Xanomeline and trospium chlorideCobenfy · 3 products
- Triamcinolone acetonideKenalog-40, Triderm, Triesence · 3 products
- AtazanavirReyataz · 3 products
- EntecavirBaraclude · 3 products
- AztreonamAzactam · 2 products
- RepotrectinibAugtyro · 2 products
- IpilimumabYervoy · 2 products
- ElotuzumabEmpliciti · 2 products
- IberdomideZenbexus · 2 products
- Nivolumab and hyaluronidase-nvhyOpdivo Qvantig · 2 products
- Atazanavir and cobicistatEvotaz · 1 product
- BelataceptNulojix · 1 product
- HalcinonideHalog · 1 product
- DeucravacitinibSotyktu · 1 product
- Nivolumab and relatlimab-rmbwOpdualag · 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 13, 2026 | NDA221075 | Iberdomide ZENBEXUS | Bristol Myers Squibb |
| April 17, 2025 | NDA220073 | Apixaban ELIQUIS, ELIQUIS SPRINKLE | Bristol |
| December 27, 2024 | BLA761381 | Nivolumab and hyaluronidase-nvhy OPDIVO QVANTIG | Bristol-Myers Squibb |
| September 26, 2024 | NDA216158 | Xanomeline and trospium chloride COBENFY | Bristol-Myers |
| November 15, 2023 | NDA218213 | Repotrectinib AUGTYRO | Bristol |
| September 9, 2022 | NDA214958 | Deucravacitinib SOTYKTU | Bristol |
| March 18, 2022 | BLA761234 | Nivolumab and relatlimab-rmbw OPDUALAG | Bristol Myers Squibb |
| November 30, 2015 | BLA761035 | Elotuzumab EMPLICITI | Bristol Myers Squibb |
| January 29, 2015 | NDA206353 | Atazanavir and cobicistat EVOTAZ | Bristol |
| December 22, 2014 | BLA125554 | Nivolumab OPDIVO | Bristol Myers Squibb |
| June 2, 2014 | NDA206352 | Atazanavir REYATAZ | Bristol Myers Squibb |
| December 28, 2012 | NDA202155 | Apixaban ELIQUIS | Bristol Myers Squibb |
| June 15, 2011 | BLA125288 | Belatacept NULOJIX | Bristol Myers Squibb |
| March 25, 2011 | BLA125377 | Ipilimumab YERVOY | Bristol Myers Squibb |
| June 28, 2006 | NDA021986 | Dasatinib SPRYCEL | Bristol Myers Squibb |
| December 23, 2005 | BLA125118 | Abatacept ORENCIA | Bristol Myers Squibb |
| March 29, 2005 | NDA021797 | Entecavir BARACLUDE | Bristol Myers Squibb |
| March 29, 2005 | NDA021798 | Entecavir BARACLUDE | Bristol Myers Squibb |
| June 20, 2003 | NDA021567 | Atazanavir REYATAZ | Bristol Myers Squibb |
| December 31, 1986 | NDA050580 | Aztreonam AZACTAM | Labs Delbert |
| May 4, 1977 | NDA017823 | Halcinonide HALOG | Sun Pharm Inds Inc |
| February 1, 1965 | NDA014901 | Triamcinolone acetonide KENALOG-40, KENALOG-80 | Apothecon |
| January 4, 1960 | NDA012041 | Triamcinolone acetonide KENALOG-10 | Apothecon |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
-
October 21, 2025 · Class II · Ongoing · D-0097-2026 · Nivolumab and relatlimab-rmbw
Lack of Assurance of Sterility.
Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11
2017
-
June 5, 2017 · Class I · Terminated · D-0959-2017 · Apixaban
Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21
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).
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