Drug company (FDA labeler)
Florida Pharmaceutical Products, LLC
NDC labeler codes: 69076, 71921
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
- Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 5 products
- LacosamideVimpat, Motpoly XR · 5 products
- IbuprofenIbu, Caldolor · 3 products
- AllopurinolAloprim · 3 products
- Glimepiride3 products
- RasagilineAzilect · 2 products
- DapagliflozinFarxiga · 2 products
- Varenicline tartrateChantix, Tyrvaya · 2 products
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 2 products
- Abiraterone acetateZytiga, Abirtega, Yonsa · 2 products
- Brimonidine tartrate and timolol maleateCombigan · 1 product
- ExemestaneAromasin · 1 product
- ValganciclovirValcyte · 1 product
- Dorzolamide hydrochloride and timolol maleateCosopt, Dorzolamide Hydrochloride Timolol Maletae, Cosopt Pf · 1 product
- RivaroxabanXarelto · 1 product
- RiluzoleTiglutik · 1 product
- Dorzolamide hydrochloride1 product
- Aminocaproic acid1 product
- Lofexidine hydrochlorideLucemyra · 1 product
- Mercaptopurine1 product
- SumatriptanImitrex, Tosymra, Zembrace Symtouch · 1 product
- Brimonidine tartrateAlphagan P, Mirvaso · 1 product
- BrivaracetamBriviact · 1 product
- Tenofovir disoproxil fumarateViread · 1 product
- AcyclovirZovirax, Avaclyr · 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 |
|---|---|---|---|
| April 6, 2026 | ANDA211156 | Dapagliflozin DAPAGLIFLOZIN | Inventia |
| February 23, 2026 | ANDA220385 | Brivaracetam BRIVARACETAM | Regcon Holdings |
| January 29, 2026 | ANDA220386 | Lacosamide LACOSAMIDE | Regcon Holdings |
| August 11, 2025 | ANDA218445 | Rivaroxaban RIVAROXABAN | Regcon Holdings |
| October 29, 2024 | ANDA219106 | Varenicline tartrate VARENICLINE TARTRATE | Regcon Holdings |
| August 20, 2024 | ANDA218613 | Lofexidine hydrochloride LOFEXIDINE HYDROCHLORIDE | Regcon Holdings |
| April 11, 2023 | ANDA216317 | Valganciclovir VALGANCICLOVIR HYDROCHLORIDE | Appco |
| March 23, 2023 | ANDA215086 | Abiraterone acetate ABIRATERONE ACETATE | Regcon Holdings |
| October 4, 2022 | ANDA201949 | Brimonidine tartrate and timolol maleate BRIMONIDINE TARTRATE AND TIMOLOL MALEATE | Regcon Holdings |
| March 23, 2022 | ANDA215510 | Aminocaproic acid AMINOCAPROIC ACID | Regcon Holdings |
| March 17, 2022 | ANDA208308 | Lacosamide LACOSAMIDE | Regcon Holdings |
| February 17, 2021 | ANDA208967 | Sumatriptan SUMATRIPTAN | Regcon Holdings |
| July 28, 2020 | ANDA213474 | Doxepin hydrochloride DOXEPIN HYDROCHLORIDE | Aiping Pharm Inc |
| April 13, 2020 | ANDA213547 | Exemestane EXEMESTANE | Qilu |
| December 9, 2019 | ANDA206045 | Riluzole RILUZOLE | Kenton |
| October 4, 2019 | ANDA206153 | Rasagiline RASAGILINE MESYLATE | Regcon Holdings |
| September 27, 2019 | ANDA212462 | Abiraterone acetate ABIRATERONE ACETATE | Qilu |
| March 2, 2018 | ANDA209498 | Tenofovir disoproxil fumarate TENOFOVIR DISOPROXIL FUMARATE | Qilu |
| July 28, 2016 | ANDA204467 | Allopurinol ALLOPURINOL | Regcon Holdings |
| November 18, 2014 | ANDA091691 | Brimonidine tartrate BRIMONIDINE TARTRATE | Regcon Holdings |
| September 11, 2014 | ANDA202053 | Dorzolamide hydrochloride DORZOLAMIDE HYDROCHLORIDE | Regcon Holdings |
| September 3, 2014 | ANDA202054 | Dorzolamide hydrochloride and timolol maleate DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | Regcon Holdings |
| February 3, 2014 | ANDA091182 | Glycopyrrolate GLYCOPYRROLATE | Regcon Holdings |
| April 17, 2013 | ANDA202112 | Glimepiride GLIMEPIRIDE | Regcon Holdings |
| January 26, 1999 | ANDA075090 | Acyclovir ACYCLOVIR | Regcon Holdings |
| October 15, 1986 | ANDA071268 | Ibuprofen IBUPROFEN | Contract Pharmacal |
| September 11, 1953 | NDA009053 | Mercaptopurine PURINETHOL | Stason Pharms |
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