Drug company (FDA labeler)
Onesource Specialty Pharma Limited
Name in FDA records: ONESOURCE SPECIALTY PHARMA LIMITED
NDC labeler code: 83270
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
- Bupivacaine hydrochlorideSensorcaine Mpf, Marcaine, Sensorcaine · 8 products
- MidazolamNayzilam · 7 products
- Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 6 products
- Ampicillin5 products
- SumatriptanImitrex, Tosymra, Zembrace Symtouch · 4 products
- Piperacillin and tazobactamZosyn in Galaxy Containers, Zosyn · 3 products
- LevothyroxineTirosint, Tirosint Sol, Synthroid · 3 products
- Ampicillin sodium and sulbactam sodiumUnasyn · 3 products
- Nafcillin sodium3 products
- Oxacillin2 products
- Ondansetron2 products
- LabetalolLabetalol HCL in Dextrose · 2 products
- Carboprost tromethamineHemabate · 1 product
- AcetylcysteineAcetadote · 1 product
- EtoposideVepesid, Avopef, Etopophos · 1 product
- Mycophenolate mofetilCellcept, Myhibbin · 1 product
- Thiamine hydrochloride1 product
- Methohexital sodiumBrevital Sodium · 1 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 25, 2026 | ANDA203830 | Nafcillin sodium NAFCILLIN SODIUM | Steriscience |
| March 5, 2025 | ANDA216729 | Levothyroxine LEVOTHYROXINE SODIUM | Onesource Specialty |
| November 21, 2024 | ANDA215651 | Sumatriptan SUMATRIPTAN SUCCINATE | Onesource Specialty |
| October 29, 2024 | ANDA217181 | Thiamine hydrochloride THIAMINE HYDROCHLORIDE | Onesource Specialty |
| October 3, 2024 | ANDA215488 | Methohexital sodium METHOHEXITAL SODIUM | Onesource Specialty |
| July 25, 2023 | ANDA216897 | Carboprost tromethamine CARBOPROST TROMETHAMINE | Onesource Specialty |
| April 19, 2023 | ANDA217182 | Acetylcysteine ACETYLCYSTEINE | Onesource Specialty |
| December 23, 2022 | ANDA216390 | Mycophenolate mofetil MYCOPHENOLATE MOFETIL HYDROCHLORIDE | Onesource Specialty |
| August 25, 2014 | ANDA091486 | Oxacillin OXACILLIN SODIUM | Onesource Specialty |
| August 15, 2014 | ANDA065458 | Piperacillin and tazobactam PIPERACILLIN AND TAZOBACTAM | Onesource Specialty |
| August 4, 2014 | ANDA201155 | Ketorolac tromethamine KETOROLAC TROMETHAMINE | Onesource Specialty |
| April 9, 2014 | ANDA201025 | Ampicillin AMPICILLIN SODIUM | Onesource Specialty |
| April 7, 2014 | ANDA200002 | Nafcillin sodium NAFCILLIN SODIUM | Onesource Specialty |
| April 7, 2014 | ANDA201024 | Ampicillin sodium and sulbactam sodium AMPICILLIN AND SULBACTAM | Onesource Specialty |
| April 7, 2014 | ANDA202197 | Ampicillin sodium and sulbactam sodium AMPICILLIN AND SULBACTAM | Onesource Specialty |
| April 7, 2014 | ANDA202198 | Ampicillin AMPICILLIN SODIUM | Onesource Specialty |
| October 18, 2011 | ANDA091487 | Bupivacaine hydrochloride BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | Onesource Specialty |
| October 18, 2011 | ANDA091503 | Bupivacaine hydrochloride BUPIVACAINE HYDROCHLORIDE | Onesource Specialty |
| May 4, 2011 | ANDA090316 | Midazolam MIDOZALAM HYDROCHLORIDE | Onesource Specialty |
| November 29, 2010 | ANDA090315 | Midazolam MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE | Onesource Specialty |
| July 28, 2010 | ANDA090641 | Sumatriptan SUMATRIPTAN SUCCINATE | Onesource Specialty |
| June 10, 2010 | ANDA090314 | Sumatriptan SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE (AUTOINJECTOR) | Onesource Specialty |
| February 3, 2010 | ANDA079134 | Labetalol LABETALOL HYDROCHLORIDE | Onesource Specialty |
| April 23, 2008 | ANDA078244 | Ondansetron ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | Onesource Specialty |
| April 23, 2008 | ANDA078257 | Ondansetron ONDANSETRON HYDROCHLORIDE | Onesource Specialty |
Show the other 2 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| July 16, 2007 | ANDA078299 | Ketorolac tromethamine KETOROLAC TROMETHAMINE | Onesource Specialty |
| December 30, 1986 | NDA019557 | Etoposide VEPESID | Onesource Specialty |
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.
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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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