Drug company (FDA labeler)
BioComp Pharma, Inc.
NDC labeler code: 44523
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
- TioproninThiola Ec, Venxxiva, Thiola · 3 products
- Potassium citrateUrocit-K · 2 products
- GabapentinNeurontin, Gralise, Relgaabi · 1 product
- PrednisoloneOrapred ODT · 1 product
- TinidazoleTindazole, Tindamax · 1 product
- Carbinoxamine maleateKarbinal ER, Carbzah, Ryvent · 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 |
|---|---|---|---|
| June 28, 2019 | NDA211843 | Tiopronin THIOLA EC | Mission Pharmacal |
| May 27, 2011 | ANDA090756 | Carbinoxamine maleate CARBINOXAMINE MALEATE | Mission Pharmacal |
| February 18, 2011 | ANDA078974 | Gabapentin GABAPENTIN | Mission Pharmacal |
| September 13, 2010 | ANDA091396 | Prednisolone PREDNISOLONE SODIUM PHOSPHATE | Mission Pharma |
| May 17, 2004 | NDA021618 | Tinidazole TINDAMAX | Mission Pharma |
| August 11, 1988 | NDA019569 | Tiopronin THIOLA | Mission Pharma |
| August 30, 1985 | NDA019071 | Potassium citrate UROCIT-K | Mission Pharma |
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