Drug company (FDA labeler)
Saptalis Pharmaceuticals, LLC.
NDC labeler code: 71656
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
- Chlorpromazine hydrochloride2 products
- MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 2 products
- DesoximetasoneTopicort · 2 products
- Triamcinolone acetonideKenalog-40, Triderm, Triesence · 2 products
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 2 products
- FluoxetineProzac · 1 product
- CyclosporineSandimmune, Neoral, Cyclosporine Modified · 1 product
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 1 product
- Hydrocortisone and acetic acid1 product
- TofacitinibXeljanz, Xeljanz XR · 1 product
- Fluocinonide1 product
- LevocarnitineCarnitor, Carnitor Sf · 1 product
- Lithium1 product
- Metformin hydrochlorideGlumetza · 1 product
- Hydroxyzine1 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 |
|---|---|---|---|
| June 11, 2026 | ANDA220271 | Hydroxyzine HYDROXYZINE HYDROCHLORIDE | Sciegen Pharms |
| June 9, 2026 | ANDA218900 | Tofacitinib TOFACITINIB CITRATE | Saptalis Pharms |
| December 31, 2024 | ANDA216750 | Metronidazole METRONIDAZOLE | Sciegen Pharms |
| October 7, 2024 | ANDA216297 | Glycopyrrolate GLYCOPYRROLATE | Sciegen Pharms |
| July 5, 2024 | ANDA211943 | Cyclosporine CYCLOSPORINE | Saptalis Pharms |
| March 18, 2024 | ANDA217183 | Lithium LITHIUM CITRATE | Sciegen Pharms |
| September 22, 2023 | NDA216755 | Metronidazole LIKMEZ | Saptalis Pharms |
| November 10, 2021 | ANDA212533 | Levocarnitine LEVOCARNITINE | Sciegen Pharms |
| May 21, 2021 | ANDA211648 | Potassium chloride POTASSIUM CHLORIDE | Sciegen Pharms |
| March 3, 2020 | ANDA211309 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Saptalis Pharms |
| March 18, 2019 | ANDA207554 | Fluocinonide FLUOCINONIDE | Sciegen Pharms |
| January 6, 2017 | ANDA203787 | Desoximetasone DESOXIMETASONE | Sciegen Pharms |
| June 12, 2015 | ANDA203234 | Desoximetasone DESOXIMETASONE | Sciegen Pharms |
| December 13, 2006 | ANDA040672 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Micro Labs |
| June 9, 2006 | ANDA040671 | Triamcinolone acetonide TRIAMCINOLONE ACETONIDE | Micro Labs |
| June 27, 2002 | ANDA075525 | Fluoxetine FLUOXETINE HYDROCHLORIDE | Sciegen Pharms |
| March 1, 1976 | ANDA080983 | Chlorpromazine hydrochloride SONAZINE | Sciegen Pharms |
| June 23, 1961 | NDA012770 | Hydrocortisone and acetic acid VOSOL HC | Saptalis Pharms |
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