PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Substance profile for UNII X2ELS050D8, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Substance Identity#
- UNII
- X2ELS050D8
- Preferred term
- PAROXETINE HYDROCHLORIDE HEMIHYDRATE
- Registry number
- 110429-35-1
- Ingredient type
- INGREDIENT SUBSTANCE
- Molecular formula
- 2C19H20FNO3.2ClH.H2O

Chemical And Database Identifiers#
- InChIKey
- MQZOATSIFWSKKT-OASXIEIISA-N
- SMILES
- O.Cl.Cl.FC1=CC=C(C=C1)[C@@H]2CCNC[C@H]2COC3=CC4=C(OCO4)C=C3.FC5=CC=C(C=C5)[C@@H]6CCNC[C@H]6COC7=CC8=C(OCO8)C=C7
- RxCUI
- 1298842
- PubChem
- 5282487
- NCIt
- C82238
- INN ID
- 0
Open Chemistry Sources#
| Source | Identifier | Link |
|---|---|---|
| PubChem Compound | 5282487 | https://pubchem.ncbi.nlm.nih.gov/compound/5282487 |
| PubChem InChIKey Search | MQZOATSIFWSKKT-OASXIEIISA-N | https://pubchem.ncbi.nlm.nih.gov/#query=MQZOATSIFWSKKT-OASXIEIISA-N |
| RxNorm | 1298842 | https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1298842 |
| NCI Thesaurus | C82238 | https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C82238 |
| FDA Substance Registration System | X2ELS050D8 | https://precision.fda.gov/uniisearch/srs/unii/X2ELS050D8 |
Related DailyMed Labels#
| Label | Manufacturer | Effective date |
|---|---|---|
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Rhodes Pharmaceuticals LLC | Quotient Sciences-Philadelphia, LLC | Beijing Sciecure Pharmaceutical Co., Ltd. | 2026-05-26 |
| Paroxetine | American Health Packaging | 2026-05-13 |
| PAROXETINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited | 2026-04-29 |
| Paroxetine hydrochloride | Evereen Shanghai Biotechnology Ltd. | Zhejiang Haisen Pharmaceutical Co., Ltd. | 2026-04-27 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 2026-04-16 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 2026-04-09 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Alembic Pharmaceuticals Limited | 2026-04-03 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 2026-04-01 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | AvPAK | 2026-03-24 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 2026-03-11 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | DIRECT RX | 2026-03-05 |
| Paroxetine | A-S Medication Solutions | 2026-02-20 |
| paroxetine hydrochloride hemihydrate | Mylan Pharmaceuticals Inc. | 2026-02-12 |
| paroxetine hydrochloride hemihydrate | REMEDYREPACK INC. | 2026-02-12 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 2026-02-09 |
| Paroxetine | A-S Medication Solutions | 2026-02-06 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | REMEDYREPACK INC. | 2026-02-06 |
| paroxetine hydrochloride hemihydrate | REMEDYREPACK INC. | 2026-02-05 |
| paroxetine hydrochloride hemihydrate | REMEDYREPACK INC. | 2026-02-05 |
| paroxetine hydrochloride hemihydrate | NuCare Pharmaceuticals, Inc. | 2026-02-02 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | NuCare Pharamceuticals, Inc. | 2026-02-02 |
| paroxetine hydrochloride hemihydrate | Preferred Pharmaceuticals Inc. | 2026-01-21 |
| paroxetine hydrochloride hemihydrate | REMEDYREPACK INC. | 2026-01-19 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Yiling Pharmaceutical, Inc. | Yiling Pharmaceutical Ltd | 2025-12-30 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Chartwell RX, LLC. | 2025-12-22 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | PD-Rx Pharmaceuticals, Inc. | 2025-10-20 |
| PAXIL CR | Apotex Corp | Apotex Inc. | 2025-09-22 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Apotex Corp | Apotex Inc. | 2025-09-22 |
| Paroxetine | Preferred Pharmaceuticals Inc. | 2025-09-08 |
| Paroxetine | Preferred Pharmaceuticals Inc. | 2025-09-05 |
| Paroxetine | Preferred Pharmaceuticals, Inc | 2025-09-05 |
| paroxetine hydrochloride hemihydrate | NuCare Pharmaceuticals, Inc. | 2025-08-13 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | 2025-07-08 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | 2025-07-08 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | 2025-07-08 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | NorthStar Rx LLC | Aurobindo Pharma Limited | 2025-06-16 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Aurolife Pharma LLC | Aurobindo Pharma Limited | 2025-06-07 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Aurobindo Pharma Limited | 2025-05-15 |
| paroxetine hydrochloride hemihydrate | PD-Rx Pharmaceuticals, Inc. | 2025-05-05 |
| paroxetine hydrochloride hemihydrate | PD-Rx Pharmaceuticals, Inc. | 2025-05-05 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | 2025-03-28 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | 2025-03-28 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | 2025-03-21 |
| paroxetine hydrochloride hemihydrate | PD-Rx Pharmaceuticals, Inc. | 2025-02-19 |
| paroxetine hydrochloride hemihydrate | PD-Rx Pharmaceuticals, Inc. | 2025-02-19 |
| paroxetine hydrochloride hemihydrate | Preferred Pharmaceuticals Inc. | 2025-02-13 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-02-13 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Direct_Rx | 2025-01-22 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited | 2025-01-07 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 |
| paroxetine hydrochloride hemihydrate | Solco Healthcare US, LLC | Prinston Pharmaceutical Inc. | Zhejiang Huahai Pharmaceutical Co. Ltd | Zhejiang Huahai Pharmaceutical Technology Co., Ltd. | 2024-12-31 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Coupler LLC | 2024-11-11 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Coupler LLC | Zydus Pharmaceuticals USA Inc. | 2024-11-08 |
| PAXIL | Apotex Corp | 2024-10-22 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | ANI Pharmaceuticals, Inc. | Novitium Pharma LLC | 2024-09-16 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | 2024-09-06 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | 2024-08-29 |
| paroxetine hydrochloride | Oxford Pharmaceuticals, LLC | 2024-08-09 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | NuCare Pharmaceuticals,Inc. | 2024-07-15 |
| paroxetine hydrochloride hemihydrate | Bryant Ranch Prepack | 2024-06-28 |
| paroxetine hydrochloride hemihydrate | Proficient Rx LP | 2024-06-27 |
| paroxetine hydrochloride hemihydrate | Proficient Rx LP | 2024-05-01 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Modavar Pharmaceuticals LLC | Cadila Pharmaceuticals Limited | 2024-04-24 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Cadila Pharmaceuticals Limited | 2024-03-28 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | 2024-01-11 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Lupin Pharmaceuticals, Inc. | LUPIN LIMITED | 2023-10-31 |
| Paroxetine | Westminster Pharmaceuticals, LLC | Visum Pharmaceutical Co. | 2023-10-05 |
| Paroxetine Hydrochloride | Lannett Company, Inc. | 2023-08-22 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | DIRECT RX | 2023-05-10 |
| Paroxetine | Chartwell RX, LLC | 2022-12-13 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Sinotherapeutics Inc. | Haimen Pharma Inc. | 2022-10-31 |
| paroxetine hydrochloride hemihydrate | NCS HealthCare of KY, LLC dba Vangard Labs | 2022-09-02 |
| Paroxetine | NCS HealthCare of KY, LLC dba Vangard Labs | 2022-09-02 |
| paroxetine hydrochloride hemihydrate | Proficient Rx LP | 2022-05-02 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Northwind Pharmaceuticals | 2021-12-31 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | NuCare Pharmaceuticals,Inc. | 2021-02-19 |
| paroxetine hydrochloride hemihydrate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 2021-01-25 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | NuCare Pharmaceuticals,Inc. | 2021-01-11 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Proficient Rx LP | 2021-01-01 |
| PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Proficient Rx LP | 2021-01-01 |
Related NDC Products#
| NDC | Name | Nonproprietary name | Labeler | Marketing category |
|---|---|---|---|---|
| 0378-7001 | Paroxetine | paroxetine hydrochloride hemihydrate | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-7002 | Paroxetine | paroxetine hydrochloride hemihydrate | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-7003 | Paroxetine | paroxetine hydrochloride hemihydrate | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-7004 | Paroxetine | paroxetine hydrochloride hemihydrate | Mylan Pharmaceuticals Inc. | ANDA |
| 0615-7985 | Paroxetine | paroxetine hydrochloride hemihydrate | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 13107-154 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA |
| 13107-155 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA |
| 13107-156 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA |
| 13107-157 | Paroxetine | Paroxetine | Aurolife Pharma LLC | ANDA |
| 16714-181 | Paroxetine | Paroxetine Hydrochloride | NorthStar Rx LLC | ANDA |
| 16714-182 | Paroxetine | Paroxetine Hydrochloride | NorthStar Rx LLC | ANDA |
| 16714-183 | Paroxetine | Paroxetine Hydrochloride | NorthStar Rx LLC | ANDA |
| 16714-184 | Paroxetine | Paroxetine Hydrochloride | NorthStar Rx LLC | ANDA |
| 42858-703 | PAROXETINE | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Rhodes Pharmaceuticals LLC | ANDA |
| 42858-705 | PAROXETINE | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Rhodes Pharmaceuticals LLC | ANDA |
| 42858-707 | PAROXETINE | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Rhodes Pharmaceuticals LLC | ANDA |
| 43353-544 | Paroxetine | paroxetine hydrochloride hemihydrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-554 | Paroxetine | paroxetine hydrochloride hemihydrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43353-713 | Paroxetine | Paroxetine | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 43547-347 | Paroxetine | paroxetine hydrochloride hemihydrate | Solco Healthcare US, LLC | ANDA |
| 43547-348 | Paroxetine | paroxetine hydrochloride hemihydrate | Solco Healthcare US, LLC | ANDA |
| 43547-349 | Paroxetine | paroxetine hydrochloride hemihydrate | Solco Healthcare US, LLC | ANDA |
| 43547-350 | Paroxetine | paroxetine hydrochloride hemihydrate | Solco Healthcare US, LLC | ANDA |
| 46708-766 | Paroxetine | Paroxetine | Alembic Pharmaceuticals Limited | ANDA |
| 46708-767 | Paroxetine | Paroxetine | Alembic Pharmaceuticals Limited | ANDA |
| 46708-768 | Paroxetine | Paroxetine | Alembic Pharmaceuticals Limited | ANDA |
| 50090-5987 | Paroxetine | paroxetine hydrochloride hemihydrate | A-S Medication Solutions | ANDA |
| 50268-640 | Paroxetine | Paroxetine | AvPAK | ANDA |
| 50268-642 | Paroxetine | Paroxetine | AvPAK | ANDA |
| 50268-643 | Paroxetine | Paroxetine | AvPAK | ANDA |
| 55289-037 | Paroxetine | paroxetine hydrochloride hemihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 55289-053 | Paroxetine | paroxetine hydrochloride hemihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 55289-972 | Paroxetine | Paroxetine | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 60505-1317 | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | Apotex Corp | NDA AUTHORIZED GENERIC |
| 60505-1318 | PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | Apotex Corp | NDA AUTHORIZED GENERIC |
| 61919-513 | PAROXETINE | PAROXETINE | DIRECT RX | ANDA |
| 62135-541 | PAROXETINE | PAROXETINE | Chartwell RX, LLC. | ANDA |
| 62135-542 | PAROXETINE | PAROXETINE | Chartwell RX, LLC. | ANDA |
| 62135-543 | PAROXETINE | PAROXETINE | Chartwell RX, LLC. | ANDA |
| 62135-544 | PAROXETINE | PAROXETINE | Chartwell RX, LLC. | ANDA |
| 62332-766 | Paroxetine | Paroxetine | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-767 | Paroxetine | Paroxetine | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-768 | Paroxetine | Paroxetine | Alembic Pharmaceuticals Inc. | ANDA |
| 63187-105 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA |
| 63187-190 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA |
| 63187-434 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA |
| 63187-564 | Paroxetine | Paroxetine | Proficient Rx LP | ANDA |
| 63187-927 | Paroxetine | paroxetine hydrochloride hemihydrate | Proficient Rx LP | ANDA |
| 63629-1840 | Paroxetine | Paroxetine | Bryant Ranch Prepack | ANDA |
| 63629-3349 | Paroxetine | Paroxetine | Bryant Ranch Prepack | ANDA |
| 63629-8527 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Bryant Ranch Prepack | ANDA |
| 63629-9498 | PAROXETINE | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | ANDA |
| 63629-9499 | PAROXETINE | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | ANDA |
| 63629-9500 | PAROXETINE | PAROXETINE HYDROCHLORIDE HEMIHYDRATE | Bryant Ranch Prepack | ANDA |
| 65862-154 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA |
| 65862-155 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA |
| 65862-156 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA |
| 65862-157 | Paroxetine | Paroxetine Hydrochloride | Aurobindo Pharma Limited | ANDA |
| 68071-1740 | Paroxetine | Paroxetine | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2535 | Paroxetine | Paroxetine | NuCare Pharamceuticals, Inc. | ANDA |
| 68071-2835 | Paroxetine | paroxetine hydrochloride hemihydrate | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3843 | Paroxetine | paroxetine hydrochloride hemihydrate | NuCare Pharmaceuticals, Inc. | ANDA |
| 68180-645 | PAROXETINE | PAROXETINE | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-646 | PAROXETINE | PAROXETINE | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-647 | PAROXETINE | PAROXETINE | Lupin Pharmaceuticals, Inc. | ANDA |
| 68382-001 | Paroxetine | Paroxetine | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-097 | Paroxetine | Paroxetine | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-098 | Paroxetine | Paroxetine | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-099 | Paroxetine | Paroxetine | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68788-8777 | Paroxetine | paroxetine hydrochloride hemihydrate | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8829 | Paroxetine | paroxetine hydrochloride hemihydrate | Preferred Pharmaceuticals Inc. | ANDA |
| 69117-0024 | Paroxetine | Paroxetine | Yiling Pharmaceutical, Inc. | ANDA |
| 69117-0025 | Paroxetine | Paroxetine | Yiling Pharmaceutical, Inc. | ANDA |
| 69117-0026 | Paroxetine | Paroxetine | Yiling Pharmaceutical, Inc. | ANDA |
| 69117-0027 | Paroxetine | Paroxetine | Yiling Pharmaceutical, Inc. | ANDA |
| 70518-0003 | Paroxetine | Paroxetine | REMEDYREPACK INC. | ANDA |
| 70518-1253 | Paroxetine | paroxetine hydrochloride hemihydrate | REMEDYREPACK INC. | ANDA |
| 70518-1406 | Paroxetine | paroxetine hydrochloride hemihydrate | REMEDYREPACK INC. | ANDA |
| 70518-2376 | Paroxetine | paroxetine hydrochloride hemihydrate | REMEDYREPACK INC. | ANDA |
| 70518-2387 | Paroxetine | paroxetine hydrochloride hemihydrate | REMEDYREPACK INC. | ANDA |
| 0378-2003 | Paroxetine Hydrochloride | paroxetine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-2004 | Paroxetine Hydrochloride | paroxetine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA |
| 0378-2005 | Paroxetine Hydrochloride | paroxetine hydrochloride | Mylan Pharmaceuticals Inc. | ANDA |
| 0615-5576 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA |
| 0615-5577 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA |
| 0615-5578 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA |
| 0615-5579 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA |
| 0615-8173 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA |
| 0615-8174 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA |
| 0615-8359 | Paroxetine | Paroxetine | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA |
| 33261-090 | Paroxetine | Paroxetine | Aidarex Pharmaceuticals LLC | ANDA |
| 33261-091 | Paroxetine | Paroxetine | Aidarex Pharmaceuticals LLC | ANDA |
| 35356-892 | Paroxetine | Paroxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA |
| 43063-170 | Paroxetine | paroxetine hydrochloride hemihydrate | PD-Rx Pharmaceuticals, Inc. | ANDA |