Drug company (FDA labeler)
Health Department, Oklahoma State
NDC labeler code: 83112
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
- DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 3 products
- AzithromycinZithromax, Azasite · 1 product
- Cefixime1 product
- AmoxicillinAmoxil · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| October 7, 2019 | ANDA209402 | Doxycycline DOXYCYCLINE HYCLATE | Changzhou Pharm |
| October 25, 2018 | ANDA208249 | Azithromycin AZITHROMYCIN | Cspc Ouyi |
| October 9, 2018 | ANDA210574 | Cefixime CEFIXIME | Alkem Labs Ltd |
| November 9, 2005 | ANDA065271 | Amoxicillin AMOXICILLIN | Aurobindo |
| September 11, 1984 | ANDA062500 | Doxycycline DOXYCYCLINE HYCLATE | Chartwell |
| November 8, 1982 | ANDA062269 | Doxycycline DOXYCYCLINE HYCLATE | Epic Pharma LLC |
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