Drug company (FDA labeler)
Archis Pharma LLC
NDC labeler code: 72819
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
- MitomycinMutamycin · 4 products
- PaliperidoneInvega · 3 products
- Cupric chlorideCopper · 2 products
- Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 2 products
- Imatinib mesylateGleevec, Imkeldi · 2 products
- Mycophenilic acid2 products
- NicardipineCardene IV · 1 product
- DiclofenacZipsor, Lofena, Cambia · 1 product
- Chromic chlorideChromium · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| November 18, 2024 | ANDA218538 | Chromic chloride CHROMIC CHLORIDE | Somerset Theraps LLC |
| April 30, 2024 | ANDA217626 | Cupric chloride CUPRIC CHLORIDE | Stira |
| June 21, 2022 | ANDA212135 | Imatinib mesylate IMATINIB MESYLATE | Qilu Pharm Hainan |
| October 13, 2017 | ANDA202670 | Mitomycin MITOMYCIN | Adaptis |
| October 13, 2017 | ANDA203386 | Mitomycin MITOMYCIN | Adaptis |
| January 20, 2016 | ANDA202337 | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE | Rk Pharma |
| September 24, 2015 | ANDA203802 | Paliperidone PALIPERIDONE | Rk Pharma |
| January 8, 2014 | ANDA091248 | Mycophenilic acid MYCOPHENOLATE SODIUM | Rk Pharma |
| November 17, 2009 | ANDA090664 | Nicardipine NICARDIPINE HYDROCHLORIDE | Somerset Theraps LLC |
| July 26, 1999 | ANDA075463 | Diclofenac DICLOFENAC POTASSIUM | Rising |
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