Drug company (FDA labeler)
BPI Labs LLC
NDC labeler code: 54288
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
- EpinephrineAuvi-Q, Adrenalin, Adrenalin (Epinephrine in Sodium Chloride) · 6 products
- CarboplatinKyxata · 4 products
- TacrolimusPrograf, Envarsus XR, Astagraf XL · 3 products
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 3 products
- Testosterone cypionateDepo-Testosterone, Azmiro · 2 products
- Zoledronic acidReclast · 2 products
- AlcoholDehydrated Alcohol · 2 products
- Mycophenolate mofetilCellcept, Myhibbin · 1 product
- Trimethobenzamide hydrochlorideTigan · 1 product
- Levofloxacin1 product
- Fluorescein (fluorescein sodium)Ak-Fluor · 1 product
- Naloxone hydrochlorideNarcan, Rextovy, Zimhi · 1 product
- Aminocaproic acid1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 3, 2026 | ANDA219478 | Testosterone cypionate TESTOSTERONE CYPIONATE | Bpi Labs |
| April 30, 2026 | ANDA220046 | Fluorescein (fluorescein sodium) FLUORESCEIN SODIUM | Bpi Labs |
| October 16, 2025 | ANDA219606 | Trimethobenzamide hydrochloride TRIMETHOBENZAMIDE HYDROCHLORIDE | Bpi Labs |
| October 6, 2023 | ANDA216977 | Naloxone hydrochloride NALOXONE HYDROCHLORIDE | Bpi Labs |
| June 1, 2023 | ANDA214283 | Mycophenolate mofetil MYCOPHENOLATE MOFETIL HYDROCHLORIDE | Bpi Labs |
| March 7, 2023 | ANDA216156 | Potassium chloride POTASSIUM CHLORIDE | Ajenat Pharms |
| April 8, 2021 | ANDA213825 | Aminocaproic acid AMINOCAPROIC ACID | Ajenat Pharms |
| May 6, 2019 | ANDA212183 | Potassium chloride POTASSIUM CHLORIDE | Ajenat Pharms |
| February 27, 2019 | ANDA205600 | Levofloxacin LEVOFLOXACIN | Micro Labs Ltd India |
| June 21, 2018 | NDA207987 | Alcohol ABLYSINOL | Bpi Labs |
| December 29, 2017 | ANDA207341 | Zoledronic acid ZOLEDRONIC ACID | Bpi Labs |
| November 30, 2017 | ANDA206651 | Tacrolimus TACROLIMUS | Ajenat Pharms |
| February 15, 2017 | ANDA207324 | Carboplatin CARBOPLATIN | Gland |
| July 29, 2014 | NDA205029 | Epinephrine EPINEPHRINE | Bpi Labs |
| August 5, 2013 | ANDA202930 | Zoledronic acid ZOLEDRONIC ACID | Gland |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
No recall of these products (by NDC code) appears in the FDA enforcement reports.
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