Drug company (FDA labeler)
ScieGen Pharmaceuticals, Inc.
NDC labeler code: 50228
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
- PregabalinLyrica, Lyrica CR · 19 products
- AripiprazoleAbilify, Opipza, Abilify Asimtufii · 14 products
- DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 10 products
- Metformin hydrochlorideGlumetza · 9 products
- FluoxetineProzac · 7 products
- GabapentinNeurontin, Gralise, Relgaabi · 7 products
- LevetiracetamKeppra, Spritam, Keppra XR · 6 products
- BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 6 products
- Pramipexole dihydrochloride6 products
- Valsartan and hydrochlorothiazideDiovan Hct · 5 products
- NaproxenNaprelan, Rugby All Day Relief · 5 products
- QuetiapineSeroquel, Seroquel XR · 5 products
- Carbidopa and levodopaCrexont, Rytary, Sinemet · 5 products
- BrivaracetamBriviact · 5 products
- RosuvastatinCrestor · 4 products
- LacosamideVimpat, Motpoly XR · 4 products
- AtorvastatinLipitor · 4 products
- ValsartanDiovan · 4 products
- LamotrigineLamictal, Lamictal XR, Subvenite · 4 products
- CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 4 products
- Amlodipine and olmesartan medoxomilAzor · 4 products
- Hydralazine hydrochloride4 products
- Enalapril maleateVasotec, Epaned · 4 products
- Olmesartan medoxomilBenicar · 3 products
- DroxidopaNorthera · 3 products
- Sertraline hydrochlorideZoloft · 3 products
- Benztropine mesylate3 products
- HydrochlorothiazideInzirqo · 3 products
- IrbesartanAvapro · 3 products
- Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 3 products
- PirfenidoneEsbriet · 3 products
- Omeprazole and sodium bicarbonateZegerid · 2 products
- Metaxalone2 products
- ClopidogrelPlavix · 2 products
- Donepezil hydrochlorideAricept · 2 products
- NabumetoneRelafen Ds · 2 products
- RanolazineAspruzyo Sprinkle · 2 products
- TicagrelorBrilinta · 2 products
- Naproxen and esomeprazole magnesium2 products
- MetoclopramideReglan, Gimoti · 2 products
- Solifenacin succinate2 products
- CarisoprodolSoma · 1 product
- ClotrimazoleClotic (Clotrimazole) Otic Solution · 1 product
- Ethacrynic acidEdecrin · 1 product
- RivaroxabanXarelto · 1 product
- Raloxifene hydrochlorideEvista · 1 product
- PhytonadioneVitamin K1 · 1 product
- TofacitinibXeljanz, Xeljanz XR · 1 product
- Levocetirizine dihydrochlorideXyzal · 1 product
- EzetimibeZetia · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| July 1, 2026 | ANDA219952 | Brivaracetam BRIVARACETAM | Sciegen Pharms |
| June 25, 2026 | ANDA220972 | Tofacitinib TOFACITINIB CITRATE | Sciegen Pharms |
| April 23, 2026 | ANDA204687 | Valsartan and hydrochlorothiazide VALSARTAN AND HYDROCHLOROTHIAZIDE | Sciegen Pharms |
| March 31, 2026 | ANDA208465 | Olmesartan medoxomil and hydrochlorothiazide OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Sciegen Pharms |
| October 28, 2025 | ANDA218962 | Ticagrelor TICAGRELOR | Sciegen Pharms |
| September 19, 2025 | ANDA218491 | Gabapentin GABAPENTIN | Sciegen Pharms |
| July 31, 2025 | ANDA218117 | Rivaroxaban RIVAROXABAN | Sciegen Pharms |
| October 16, 2023 | ANDA216569 | Clotrimazole CLOTRIMAZOLE | Sciegen Pharms |
| October 11, 2023 | ANDA217738 | Naproxen and esomeprazole magnesium NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Sciegen Pharms |
| July 28, 2023 | ANDA213329 | Phytonadione PHYTONADIONE | Sciegen Pharms |
| April 6, 2023 | ANDA216327 | Diltiazem DILTIAZEM HYDROCHLORIDE | Sciegen Pharms |
| September 23, 2022 | ANDA216521 | Diltiazem DILTIAZEM HYDROCHLORIDE | Sciegen Pharms |
| September 14, 2022 | ANDA215675 | Pregabalin PREGABALIN | Sciegen Pharms |
| August 1, 2022 | ANDA212077 | Pirfenidone PIRFENIDONE | Sciegen Pharms |
| August 1, 2022 | ANDA212078 | Pirfenidone PIRFENIDONE | Sciegen Pharms |
| March 17, 2022 | ANDA205237 | Lacosamide LACOSAMIDE | Sciegen Pharms |
| February 22, 2022 | ANDA214629 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Sciegen Pharms |
| October 27, 2021 | ANDA204038 | Valsartan VALSARTAN | Sciegen Pharms |
| October 5, 2021 | ANDA214091 | Carbidopa and levodopa CARBIDOPA AND LEVODOPA | Sciegen Pharms |
| June 11, 2021 | ANDA215069 | Levetiracetam LEVETIRACETAM | Sciegen Pharms |
| May 7, 2021 | ANDA214092 | Carbidopa and levodopa CARBIDOPA AND LEVODOPA | Sciegen Pharms |
| April 16, 2021 | ANDA213334 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Sciegen Pharms |
| February 18, 2021 | ANDA214017 | Droxidopa DROXIDOPA | Sciegen Pharms |
| December 3, 2020 | ANDA205129 | Celecoxib CELECOXIB | Sciegen Pharms |
| November 27, 2020 | ANDA205130 | Levetiracetam LEVETIRACETAM | Sciegen Pharms |
| October 23, 2020 | ANDA210673 | Ezetimibe EZETIMIBE | Sciegen Pharms |
| February 21, 2020 | ANDA212517 | Naproxen NAPROXEN | Sciegen Pharms |
| October 30, 2019 | ANDA212199 | Naproxen NAPROXEN SODIUM | Sciegen Pharms |
| August 27, 2019 | ANDA211232 | Ethacrynic acid ETHACRYNIC ACID | Sciegen Pharms |
| July 19, 2019 | ANDA208677 | Pregabalin PREGABALIN | Sciegen Pharms |
| June 4, 2019 | ANDA211829 | Ranolazine RANOLAZINE | Sciegen Pharms |
| May 20, 2019 | ANDA211657 | Solifenacin succinate SOLIFENACIN SUCCINATE | Sciegen Pharms |
| April 24, 2019 | ANDA206381 | Rosuvastatin ROSUVASTATIN CALCIUM | Sciegen Pharms |
| March 20, 2019 | ANDA210935 | Fluoxetine FLUOXETINE HYDROCHLORIDE | Sciegen Pharms |
| January 14, 2019 | ANDA203561 | Hydrochlorothiazide HYDROCHLOROTHIAZIDE | Sciegen Pharms |
| January 10, 2019 | ANDA211282 | Fluoxetine FLUOXETINE HYDROCHLORIDE | Sciegen Pharms |
| December 3, 2018 | ANDA209010 | Amlodipine and olmesartan medoxomil AMLODIPINE AND OLMESARTAN MEDOXOMIL | Sciegen Pharms |
| June 29, 2018 | ANDA208130 | Olmesartan medoxomil OLMESARTAN MEDOXOMIL | Sciegen Pharms |
| April 18, 2018 | ANDA207240 | Aripiprazole ARIPIPRAZOLE | Sciegen Pharms |
| November 29, 2017 | ANDA209635 | Quetiapine QUETIAPINE FUMARATE | Sciegen Pharms |
| August 31, 2017 | ANDA207466 | Metaxalone METAXALONE | Sciegen Pharms |
| May 26, 2017 | ANDA205236 | Hydralazine hydrochloride HYDRALAZINE HYDROCHLORIDE | Sciegen Pharms |
| April 12, 2017 | ANDA207479 | Bupropion BUPROPION HYDROCHLORIDE | Sciegen Pharms |
| December 6, 2016 | ANDA207476 | Omeprazole and sodium bicarbonate OMEPRAZOLE AND SODIUM BICARBONATE | Sciegen Pharms |
| October 12, 2016 | ANDA206384 | Raloxifene hydrochloride RALOXIFENE HYDROCHLORIDE | Sciegen Pharms |
| September 29, 2016 | ANDA206383 | Aripiprazole ARIPIPRAZOLE | Sciegen Pharms |
| August 17, 2016 | ANDA206122 | Bupropion BUPROPION HYDROCHLORIDE | Sciegen Pharms |
| June 17, 2016 | ANDA206382 | Lamotrigine LAMOTRIGINE | Sciegen Pharms |
| May 19, 2016 | ANDA205519 | Atorvastatin ATORVASTATIN CALCIUM | Sciegen Pharms |
| March 1, 2016 | ANDA205794 | Bupropion BUPROPION HYDROCHLORIDE | Sciegen Pharms |
| February 18, 2016 | ANDA204989 | Gabapentin RELGAABI | Sciegen Pharms |
| February 4, 2016 | ANDA205101 | Gabapentin GABAPENTIN | Sciegen Pharms |
| December 7, 2015 | ANDA204774 | Irbesartan IRBESARTAN | Sciegen Pharms |
| March 16, 2015 | ANDA204597 | Fluoxetine FLUOXETINE HYDROCHLORIDE | Sciegen Pharms |
| October 29, 2014 | ANDA203907 | Donepezil hydrochloride DONEPEZIL HYDROCHLORIDE | Sciegen Pharms |
| October 28, 2014 | ANDA203855 | Pramipexole dihydrochloride PRAMIPEXOLE DIHYDROCHLORIDE | Sciegen Pharms |
| September 15, 2014 | ANDA204165 | Clopidogrel CLOPIDOGREL BISULFATE | Sciegen Pharms |
| September 9, 2014 | ANDA203646 | Levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE | Sciegen Pharms |
| July 23, 2014 | ANDA203018 | Hydrochlorothiazide HYDROCHLOROTHIAZIDE | Sciegen Pharms |
| January 27, 2014 | ANDA203374 | Carisoprodol CARISOPRODOL | Sciegen Pharms |
| September 11, 2013 | ANDA203769 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Sciegen Pharms |
| September 24, 2008 | ANDA078420 | Nabumetone NABUMETONE | Sciegen Pharms |
| April 30, 2007 | ANDA076442 | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE | Sciegen Pharms |
| March 23, 2001 | ANDA075178 | Enalapril maleate ENALAPRIL MALEATE | Aiping Pharm Inc |
| December 12, 1996 | ANDA040103 | Benztropine mesylate BENZTROPINE MESYLATE | Aiping Pharm Inc |
| January 30, 1990 | ANDA072215 | Metoclopramide METOCLOPRAMIDE HYDROCHLORIDE | Aiping Pharm Inc |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2023
-
February 17, 2023 · Class III · Terminated · D-0354-2023 · Gabapentin
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen Pharmaceuticals Inc., Hauppauge, NY 11788, NDC: 50228-177-05.
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