Drug company (FDA labeler)
Ingenus Pharmaceuticals, LLC
NDC labeler code: 50742
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
- DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 8 products
- FentanylFentanyl System · 8 products
- Pramipexole dihydrochloride7 products
- Desipramine hydrochlorideNorpramin · 6 products
- NifedipineProcardia XL · 6 products
- NitroglycerinNitrostat, Nitro-Dur, Nitroglycerin in Dextrose · 6 products
- BuprenorphineBelbuca, Brixadi, Buprenorphine Transdermal System · 5 products
- Estrogens, conjugatedPremarin, Premarin Vaginal · 5 products
- QuetiapineSeroquel, Seroquel XR · 5 products
- Leucovorin calciumVykoura · 4 products
- Buprenorphine and naloxoneZubsolv, Buprenorphine and Naloxone Sublingual Film, Suboxone · 4 products
- MetoprololToprol XL, Lopressor, Kapspargo · 4 products
- Isosorbide mononitrate3 products
- TizanidineZanaflex, Ontralfy · 3 products
- PrednisoloneOrapred ODT · 3 products
- OxcarbazepineTrileptal, Oxtellar XR · 3 products
- Mexiletine hydrochloride3 products
- CarbamazepineTegretol XR, Equetro, Carbatrol · 3 products
- Metolazone3 products
- DiclofenacZipsor, Lofena, Cambia · 2 products
- TimololTimoptic in Ocudose, Timoptic-Xe, Timoptic · 2 products
- Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 2 products
- Metformin hydrochlorideGlumetza · 2 products
- IvabradineCorlanor · 2 products
- LamivudineEpivir · 2 products
- Estradiol and norethindrone acetateLopreeza, Combipatch (Estradiol/Norethindrone Acetate Transdermal System), Etyqa · 2 products
- Triazolam2 products
- ProgesteroneCrinone, Prometrium, Endometrin · 1 product
- Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloridePylera · 1 product
- MesnaMesnex · 1 product
- Methenamine hippurate1 product
- Acetazolamide1 product
- Frovatriptan succinate1 product
- Norethindrone acetateGallifrey · 1 product
- TafluprostZioptan · 1 product
- Formoterol fumaratePerforomist · 1 product
- Arsenic trioxideTrisenox · 1 product
- CarisoprodolSoma · 1 product
- Cyproheptadine1 product
- Probenecid and colchicine1 product
Show the other 16 medicines
- Levonorgestrel and ethinyl estradiolDolishale, Twirla, Amethyst · 1 product
- Primaquine phosphate1 product
- Cabergoline1 product
- ChlorthalidoneThalitone, Hemiclor · 1 product
- Quinine sulfate1 product
- Hydralazine hydrochloride and isosorbide dinitrateBidil · 1 product
- ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 1 product
- Dorzolamide hydrochloride and timolol maleateCosopt, Dorzolamide Hydrochloride Timolol Maletae, Cosopt Pf · 1 product
- GefitinibIressa · 1 product
- MesalaminePentasa, Lialda, Mesalamine Rectal · 1 product
- ScopolamineScopolamine Trandermal System, Transderm Scop · 1 product
- TolcaponeTasmar · 1 product
- Colestipol hydrochlorideColestid · 1 product
- Flunisolide1 product
- Arformoterol tartrate1 product
- Dehydrated alcohol1 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 |
|---|---|---|---|
| October 16, 2026 | ANDA219588 | Progesterone PROGESTERONE | Novast Labs |
| October 15, 2025 | ANDA214023 | Estrogens, conjugated CONJUGATED ESTROGENS | Novast Labs |
| October 15, 2025 | ANDA214025 | Estrogens, conjugated CONJUGATED ESTROGENS | Novast Labs |
| July 9, 2025 | ANDA219569 | Dehydrated alcohol DEHYDRATED ALCOHOL | Ingenus Pharms LLC |
| July 2, 2025 | ANDA218032 | Diltiazem DILTIAZEM HYDROCHLORIDE | Novast Labs |
| March 17, 2025 | NDA218647 | Chlorthalidone HEMICLOR | Prm Pharma |
| January 13, 2025 | ANDA218871 | Mesna MESNA | Ingenus Pharms LLC |
| December 3, 2024 | ANDA217462 | Colestipol hydrochloride COLESTIPOL HYDROCHLORIDE | Riconpharma LLC |
| November 22, 2024 | ANDA215796 | Oxcarbazepine OXCARBAZEPINE | Riconpharma LLC |
| November 18, 2024 | ANDA218156 | Arformoterol tartrate ARFORMOTEROL TARTRATE | Lexenpharm |
| October 22, 2024 | ANDA216426 | Formoterol fumarate FORMOTEROL FUMARATE | Lexenpharm |
| August 22, 2024 | ANDA218410 | Mesalamine MESALAMINE | Novast Labs |
| May 3, 2024 | ANDA215571 | Albuterol sulfate ALBUTEROL SULFATE | Lexenpharm |
| April 5, 2024 | ANDA218002 | Tafluprost TAFLUPROST | Ingenus Pharms LLC |
| July 3, 2023 | ANDA217511 | Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE | Ingenus Pharms LLC |
| May 1, 2023 | ANDA217260 | Dorzolamide hydrochloride and timolol maleate DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE | Ingenus Pharms LLC |
| February 13, 2023 | ANDA211591 | Gefitinib GEFITINIB | Qilu Pharm Hainan |
| December 2, 2022 | ANDA216404 | Carbamazepine CARBAMAZEPINE | Ingenus Pharms LLC |
| October 24, 2022 | ANDA215616 | Metolazone METOLAZONE | Renata |
| September 23, 2022 | ANDA216275 | Diclofenac DICLOFENAC SODIUM | Ingenus Pharms LLC |
| September 13, 2022 | ANDA216533 | Timolol TIMOLOL MALEATE | Ingenus Pharms LLC |
| June 16, 2022 | ANDA207802 | Flunisolide FLUNISOLIDE | Riconpharma LLC |
| June 2, 2022 | ANDA212756 | Buprenorphine and naloxone BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | Difgen Pharms |
| April 6, 2022 | ANDA213891 | Frovatriptan succinate FROVATRIPTAN SUCCINATE | Renata |
| April 6, 2022 | ANDA215586 | Hydralazine hydrochloride and isosorbide dinitrate ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | Ingenus Pharms LLC |
Show the other 35 applications
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| February 3, 2022 | ANDA213444 | Pramipexole dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE | Novast Labs |
| December 30, 2021 | ANDA214051 | Ivabradine IVABRADINE HYDROCHLORIDE | Ingenus Pharms LLC |
| October 8, 2021 | ANDA215585 | Diclofenac DICLOFENAC POTASSIUM | Ingenus Pharms LLC |
| September 23, 2021 | ANDA210272 | Buprenorphine BUPRENORPHINE | Difgen Pharms |
| January 25, 2021 | ANDA214352 | Mexiletine hydrochloride MEXILETINE HYDROCHLORIDE | Ingenus Pharms LLC |
| November 27, 2020 | ANDA210068 | Methenamine hippurate METHENAMINE HIPPURATE | Ingenus Pharms LLC |
| November 24, 2020 | ANDA212342 | Scopolamine SCOPOLAMINE | Riconpharma LLC |
| October 22, 2020 | ANDA091692 | Levonorgestrel and ethinyl estradiol DOLISHALE | Novast Labs |
| October 20, 2020 | ANDA214219 | Triazolam TRIAZOLAM | Ingenus Pharms LLC |
| July 30, 2020 | ANDA211132 | Leucovorin calcium LEUCOVORIN CALCIUM | Ingenus Pharms LLC |
| June 14, 2019 | ANDA208783 | Diltiazem DILTIAZEM HYDROCHLORIDE | Novast Labs |
| April 3, 2019 | ANDA210612 | Estradiol and norethindrone acetate ESTRADIOL AND NORETHINDRONE ACETATE | Novast Labs |
| March 12, 2019 | ANDA210267 | Tizanidine TIZANIDINE HYDROCHLORIDE | Ingenus Pharms LLC |
| March 12, 2019 | ANDA210614 | Nifedipine NIFEDIPINE | Novast Labs |
| March 5, 2019 | ANDA209675 | Clonidine CLONIDINE HYDROCHLORIDE | Novast Labs |
| November 15, 2018 | ANDA209315 | Arsenic trioxide ARSENIC TRIOXIDE | Ingenus Pharms LLC |
| November 5, 2018 | ANDA206490 | Norethindrone acetate NORETHINDRONE ACETATE | Ingenus Pharms LLC |
| November 5, 2018 | ANDA210918 | Isosorbide mononitrate ISOSORBIDE MONONITRATE | Riconpharma LLC |
| November 2, 2018 | ANDA209674 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Novast Labs |
| August 7, 2018 | ANDA208937 | Tolcapone TOLCAPONE | Ingenus Pharms LLC |
| August 1, 2018 | ANDA204735 | Cabergoline CABERGOLINE | Ingenus Pharms LLC |
| February 6, 2018 | ANDA204106 | Metoprolol METOPROLOL SUCCINATE | Novast Labs |
| December 26, 2017 | ANDA204963 | Desipramine hydrochloride DESIPRAMINE HYDROCHLORIDE | Ingenus Pharms LLC |
| November 29, 2017 | ANDA208947 | Quetiapine QUETIAPINE FUMARATE | Novast Labs |
| November 21, 2016 | ANDA206974 | Lamivudine LAMIVUDINE | Somerset Theraps LLC |
| September 30, 2016 | ANDA203434 | Acetazolamide ACETAZOLAMIDE | Novast Labs |
| August 25, 2016 | ANDA202987 | Nifedipine NIFEDIPINE | Novast Labs |
| June 23, 2016 | ANDA206043 | Primaquine phosphate PRIMAQUINE PHOSPHATE | Ingenus Pharms LLC |
| September 23, 2015 | ANDA205087 | Cyproheptadine CYPROHEPTADINE HYDROCHLORIDE | Ingenus Pharms LLC |
| July 22, 2015 | ANDA204372 | Quinine sulfate QUININE SULFATE | Ingenus Pharms LLC |
| October 22, 2008 | ANDA040823 | Carisoprodol CARISOPRODOL | Ingenus Pharms LLC |
| October 20, 2008 | ANDA077449 | Fentanyl FENTANYL-100, FENTANYL-12, FENTANYL-25 | Difgen Pharms |
| May 13, 2008 | ANDA040618 | Probenecid and colchicine PROBENECID AND COLCHICINE | Ingenus Pharms LLC |
| June 1, 2006 | NDA021959 | Prednisolone ORAPRED ODT | Advanz Pharma |
| December 10, 1985 | NDA020145 | Nitroglycerin NITRO-DUR | Uspharma |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2022
-
September 30, 2022 · Class II · Completed · D-0010-2023 · Flunisolide
Out of specification for related substances (impurities).
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
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