Drug company (FDA labeler)
H2-Pharma, LLC
NDC labeler code: 61269
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
- OlanzapineZyprexa, Zyprexa Zydis, Olanzapine Intramuscular · 11 products
- QuetiapineSeroquel, Seroquel XR · 11 products
- HydroxyureaDroxia, Hydrea, Siklos · 4 products
- ClonazepamKlonopin · 3 products
- Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloridePylera · 3 products
- ValganciclovirValcyte · 2 products
- OrlistatXenical · 2 products
- BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 2 products
- EtoposideVepesid, Avopef, Etopophos · 1 product
- CapecitabineXeloda · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 28, 2009 | NDA022257 | Valganciclovir VALCYTE | Cheplapharm |
| May 17, 2007 | NDA022047 | Quetiapine SEROQUEL XR | Cheplapharm |
| September 28, 2006 | NDA050786 | Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride PYLERA | Labs Juvise |
| July 12, 2006 | NDA021949 | Budesonide PULMICORT FLEXHALER | Cheplapharm |
| March 29, 2004 | NDA021253 | Olanzapine ZYPREXA | Cheplapharm |
| March 29, 2001 | NDA021304 | Valganciclovir VALCYTE | Cheplapharm |
| April 6, 2000 | NDA021086 | Olanzapine ZYPREXA ZYDIS | Cheplapharm |
| April 23, 1999 | NDA020766 | Orlistat XENICAL | Cheplapharm |
| April 30, 1998 | NDA020896 | Capecitabine XELODA | Cheplapharm |
| September 26, 1997 | NDA020639 | Quetiapine SEROQUEL | Cheplapharm |
| September 30, 1996 | NDA020592 | Olanzapine ZYPREXA | Cheplapharm |
| May 17, 1996 | NDA020457 | Etoposide ETOPOPHOS PRESERVATIVE FREE | Cheplapharm |
| June 4, 1975 | NDA017533 | Clonazepam KLONOPIN | Cheplapharm |
| December 7, 1967 | NDA016295 | Hydroxyurea DROXIA, HYDREA | Waylis Therap |
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