Roerig
NDC labeler code: 0049
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
- Penicillin gPfizerpen · 6 products
- VoriconazoleVfend · 5 products
- ZiprasidoneGeodon · 4 products
- AnidulafunginEraxis · 3 products
- DoxazosinCardura, Cardura XL · 3 products
- Ampicillin sodium and sulbactam sodiumUnasyn · 3 products
- GlipizideGlucotrol XL · 1 product
- FluconazoleDiflucan · 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 |
|---|---|---|---|
| February 17, 2006 | NDA021632 | Anidulafungin ERAXIS | Vicuron Holdings |
| December 19, 2003 | NDA021630 | Voriconazole VFEND | Pf Prism Cv |
| May 24, 2002 | NDA021266 | Voriconazole VFEND | Pf Prism Cv |
| May 24, 2002 | NDA021267 | Voriconazole VFEND | Pf Prism Cv |
| February 5, 2001 | NDA020825 | Ziprasidone GEODON | Viatris |
| April 26, 1994 | NDA020329 | Glipizide GLUCOTROL XL | Pfizer |
| December 23, 1993 | NDA020090 | Fluconazole DIFLUCAN | Pfizer |
| November 2, 1990 | NDA019668 | Doxazosin CARDURA | Viatris |
| December 31, 1986 | NDA050608 | Ampicillin sodium and sulbactam sodium UNASYN | Pfizer |
| August 30, 1968 | ANDA060657 | Penicillin g PFIZERPEN | Pfizer |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2020
-
May 29, 2020 · Class II · Terminated · D-1306-2020 · Ampicillin sodium and sulbactam sodium
Presence of Particulate Matter: particulate matter identified after reconstitution.
Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-8
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
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