Drug company (FDA labeler)
Guardian Drug Company
NDC labeler code: 53041
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
- Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 3 products
- Diatrizoate meglumine and diatrizoate sodiumMd Gastroview, Gastrografin · 2 products
- Omeprazole and sodium bicarbonateZegerid · 2 products
- LevetiracetamKeppra, Spritam, Keppra XR · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| November 21, 2025 | ANDA218080 | Levetiracetam LEVETIRACETAM | Adaptis |
| July 11, 2025 | ANDA219009 | Potassium chloride POTASSIUM CHLORIDE | Adaptis |
| December 30, 2022 | ANDA214892 | Potassium chloride POTASSIUM CHLORIDE | Adaptis |
| June 27, 2022 | ANDA214201 | Diatrizoate meglumine and diatrizoate sodium DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM | Adaptis |
| April 30, 2020 | ANDA212587 | Omeprazole and sodium bicarbonate OMEPRAZOLE AND SODIUM BICARBONATE | Adaptis |
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