AZITHROMYCIN MONOHYDRATE
Substance profile for UNII JTE4MNN1MD, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Substance Identity#
- UNII
- JTE4MNN1MD
- Preferred term
- AZITHROMYCIN MONOHYDRATE
- Registry number
- 121470-24-4
- Ingredient type
- INGREDIENT SUBSTANCE
- Molecular formula
- C38H72N2O12.H2O

Chemical And Database Identifiers#
- InChIKey
- HQUPLSLYZHKKQT-WVVFQGGUSA-N
- SMILES
- O.CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]3O[C@H](C)C[C@@H]([C@H]3O)N(C)C)[C@](C)(O)C[C@@H](C)CN(C)[C@H](C)[C@@H](O)[C@]1(C)O
- RxCUI
- 1298839
- PubChem
- 9897015
- NCIt
- C76215
- INN ID
- 0
Open Chemistry Sources#
| Source | Identifier | Link |
|---|---|---|
| PubChem Compound | 9897015 | https://pubchem.ncbi.nlm.nih.gov/compound/9897015 |
| PubChem InChIKey Search | HQUPLSLYZHKKQT-WVVFQGGUSA-N | https://pubchem.ncbi.nlm.nih.gov/#query=HQUPLSLYZHKKQT-WVVFQGGUSA-N |
| RxNorm | 1298839 | https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1298839 |
| NCI Thesaurus | C76215 | https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C76215 |
| FDA Substance Registration System | JTE4MNN1MD | https://precision.fda.gov/uniisearch/srs/unii/JTE4MNN1MD |
Related DailyMed Labels#
| Label | Manufacturer | Effective date |
|---|---|---|
| AZITHROMYCIN MONOHYDRATE | Sportpharm, Inc. dba Sportpharm | 2026-04-24 |
| AZITHROMYCIN MONOHYDRATE | Preferred Pharmaceuticals, Inc. | 2026-03-12 |
| AZITHROMYCIN MONOHYDRATE | Preferred Pharmaceuticals Inc. | 2026-03-11 |
| AZITHROMYCIN MONOHYDRATE | A-S Medication Solutions | 2026-02-17 |
| AZITHROMYCIN MONOHYDRATE | Epic Pharma, LLC | 2026-02-04 |
| AZITHROMYCIN MONOHYDRATE | Sportpharm LLC | 2026-02-03 |
| AZITHROMYCIN MONOHYDRATE | AvKARE | 2026-01-13 |
| AZITHROMYCIN MONOHYDRATE | REMEDYREPACK INC. | 2026-01-12 |
| AZITHROMYCIN MONOHYDRATE | REMEDYREPACK INC. | 2026-01-09 |
| AZITHROMYCIN MONOHYDRATE | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | Epic Pharma, LLC | 2025-11-20 |
| AZITHROMYCIN MONOHYDRATE | NuCare Pharmaceuticals, Inc. | 2025-09-23 |
| azithromycin monohydrate | Sagent Pharmaceuticals | 2025-07-28 |
| AZITHROMYCIN MONOHYDRATE | ASCLEMED USA INC. | 2025-06-18 |
| AZITHROMYCIN MONOHYDRATE | Hospira, Inc. | 2025-04-16 |
| azithromycin monohydrate | Athenex Pharmaceutical Division, LLC. | 2025-01-28 |
| azithromycin monohydrate | Athenex Pharmaceutical Division, LLC. | 2025-01-28 |
| AZITHROMYCIN MONOHYDRATE | DirectRx | 2025-01-21 |
| AZITHROMYCIN MONOHYDRATE | Advanced Rx Pharmacy of Tennessee, LLC | 2024-12-31 |
| AZITHROMYCIN MONOHYDRATE | Taro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceutical Industries Ltd. | 2024-12-19 |
| AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | 2024-10-11 |
| AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | 2024-10-11 |
| azithromycin monohydrate | Sagent Pharmaceuticals | 2024-09-19 |
| azithromycin monohydrate | Thea Pharma Inc. | Woodstock Sterile Solutions, Inc. | 2024-07-25 |
| AZITHROMYCIN MONOHYDRATE | A-S Medication Solutions | 2024-07-22 |
| AZITHROMYCIN MONOHYDRATE | NuCare Pharmaceuticals,Inc. | 2024-07-17 |
| AZITHROMYCIN MONOHYDRATE | RedPharm Drug | 2024-07-15 |
| AZITHROMYCIN MONOHYDRATE | NuCare Pharmaceuticals,Inc. | 2024-06-19 |
| AZITHROMYCIN MONOHYDRATE | NuCare Pharmaceuticals,Inc. | 2024-06-14 |
| AZITHROMYCIN MONOHYDRATE | NuCare Pharmaceuticals,Inc. | 2024-06-14 |
| AZITHROMYCIN MONOHYDRATE | Redpharm Drug | 2024-06-13 |
| AZITHROMYCIN MONOHYDRATE | Chartwell RX, LLC | 2024-04-09 |
| AZITHROMYCIN MONOHYDRATE | Proficient Rx LP | 2024-04-01 |
| AZITHROMYCIN MONOHYDRATE | STATE HEALTH SERVICES, TEXAS DEPARTMENT OF | 2024-02-29 |
| AZITHROMYCIN MONOHYDRATE | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2023-09-01 |
| AZITHROMYCIN MONOHYDRATE | Eugia US LLC | Eugia Pharma Specialities Limited | 2023-07-24 |
| Azithromycin monohydrate | Sun Pharmaceutical Industries Limited | Gland Pharma Limited | 2023-06-20 |
| AZITHROMYCIN MONOHYDRATE | RPK Pharmaceuticals, Inc. | 2023-06-07 |
| AZITHROMYCIN MONOHYDRATE | RPK Pharmaceuticals, Inc. | 2023-06-07 |
| AZITHROMYCIN MONOHYDRATE | A-S Medication Solutions | 2023-04-12 |
| AZITHROMYCIN MONOHYDRATE | Teva Pharmaceuticals USA, Inc. | 2023-03-01 |
| Azithromycin monohydrate | Gland Pharma Limited | 2022-12-01 |
| AZITHROMYCIN MONOHYDRATE | Proficient Rx LP | 2022-11-01 |
| AZITHROMYCIN MONOHYDRATE | Proficient Rx LP | 2022-11-01 |
| AZITHROMYCIN MONOHYDRATE | PharmPak, Inc. | 2022-10-14 |
| AZITHROMYCIN MONOHYDRATE | Proficient Rx LP | 2022-10-01 |
| AZITHROMYCIN MONOHYDRATE | Teva Pharmaceuticals USA, Inc. | 2022-07-01 |
| AZITHROMYCIN MONOHYDRATE | Teva Pharmaceuticals USA, Inc. | 2022-06-01 |
| AZITHROMYCIN MONOHYDRATE | NuCare Pharmaceuticals,Inc. | 2022-01-19 |
| AZITHROMYCIN MONOHYDRATE | Preferred Pharmaceuticals Inc. | 2022-01-10 |
| Azithromycin Monohydrate | Akorn | Akorn Operating Company LLC | 2020-10-08 |
| AZITHROMYCIN MONOHYDRATE | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2020-04-06 |
| AZITHROMYCIN MONOHYDRATE | RedPharm Drug, Inc. | 2020-01-20 |
| AZITHROMYCIN MONOHYDRATE | DIRECT RX | 2020-01-17 |
| AZITHROMYCIN MONOHYDRATE | Lupin Pharmaceuticals,Inc. | Novel Laboratories, Inc. | 2019-12-12 |
| AZITHROMYCIN MONOHYDRATE | Direct_Rx | 2019-09-17 |
| azithromycin monohydrate | Aidarex Pharmaceuticals LLC | Aidarex Pharmaceuticals | 2018-08-24 |
| AZITHROMYCIN MONOHYDRATE | Aidarex Pharmaceuticals LLC | Aidarex Pharmaceuticals | 2018-08-14 |
| azithromycin monohydrate | Aidarex Pharmaceuticals LLC | Aidarex Pharmaceuticals | 2018-08-13 |
| Azithromycin Monohydrate | MAS MANAGEMENT GROUP, INC. | 2018-01-01 |
| AZITHROMYCIN MONOHYDRATE | A-S Medication Solutions | 2017-12-13 |
| AZITHROMYCIN MONOHYDRATE | A-S Medication Solutions | 2017-12-04 |
| AZITHROMYCIN MONOHYDRATE | Unit Dose Services | 2017-11-29 |
| AZITHROMYCIN MONOHYDRATE | A-S Medication Solutions | 2017-11-28 |
| AZITHROMYCIN MONOHYDRATE | A-S Medication Solutions | 2017-11-16 |
| AZITHROMYCIN MONOHYDRATE | Central Texas Community Health Centers | 2017-09-08 |
| AZITHROMYCIN MONOHYDRATE | Central Texas Community Health Centers | 2017-08-28 |
| azithromycin monohydrate | Unit Dose Services | 2017-08-15 |
| AZITHROMYCIN MONOHYDRATE | Unit Dose Services | 2017-07-01 |
| AZITHROMYCIN MONOHYDRATE | Unit Dose Services | 2017-02-27 |
| AZITHROMYCIN MONOHYDRATE | Aidarex Pharmaceuticals LLC | 2017-02-21 |
| AZITHROMYCIN MONOHYDRATE | Department of State Health Services, Pharmacy Branch | 2016-03-11 |
| AZITHROMYCIN MONOHYDRATE | Aidarex Pharmaceuticals LLC | 2015-12-10 |
| AZITHROMYCIN MONOHYDRATE | DirectRX | 2015-11-11 |
| AZITHROMYCIN MONOHYDRATE | Medsource Pharmaceuticals | 2015-09-01 |
| AZITHROMYCIN MONOHYDRATE | DIRECT RX | 2015-08-06 |
| AZITHROMYCIN MONOHYDRATE | DIRECT RX | 2015-05-12 |
| AZITHROMYCIN MONOHYDRATE | Aphena Pharma Solutions - Tennessee, LLC | 2014-05-20 |
| Azithromycin Monohydrate | MedVantx, Inc. | Teva Pharmaceuticals USA Inc | Blenheim Pharmacal Inc. | 2013-05-16 |
| AZITHROMYCIN MONOHYDRATE | MedVantx, Inc. | Teva Pharmaceuticals USA Inc | Blenheim Pharmacal, Inc. | 2013-02-01 |
| AZITHROMYCIN MONOHYDRATE | MedVantx, Inc. | Teva Pharmaceuticals USA Inc | Blenheim Pharmacal, Inc. | 2011-10-24 |
Related NDC Products#
| NDC | Name | Nonproprietary name | Labeler | Marketing category |
|---|---|---|---|---|
| 0093-2026 | Azithromycin | Azithromycin | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-2027 | Azithromycin | Azithromycin | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0409-0144 | Azithromycin | AZITHROMYCIN | Hospira, Inc. | ANDA |
| 24658-706 | AZITHROMYCIN | AZITHROMYCIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | ANDA |
| 24658-707 | AZITHROMYCIN | AZITHROMYCIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | ANDA |
| 24658-708 | AZITHROMYCIN | AZITHROMYCIN | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | ANDA |
| 25021-180 | Azithromycin | azithromycin monohydrate | Sagent Pharmaceuticals | ANDA |
| 42291-044 | Azithromycin | Azithromycin | AvKARE | ANDA |
| 42806-147 | AZITHROMYCIN | azithromycin | Epic Pharma, LLC | ANDA |
| 42806-149 | AZITHROMYCIN | azithromycin | Epic Pharma, LLC | ANDA |
| 42806-150 | AZITHROMYCIN | azithromycin | Epic Pharma, LLC | ANDA |
| 42806-151 | AZITHROMYCIN | azithromycin | Epic Pharma, LLC | ANDA |
| 50090-6226 | AZITHROMYCIN | azithromycin | A-S Medication Solutions | ANDA |
| 50090-6296 | AZITHROMYCIN | azithromycin | A-S Medication Solutions | ANDA |
| 50111-787 | Azithromycin | Azithromycin | Teva Pharmaceuticals USA, Inc. | ANDA |
| 50111-788 | Azithromycin | Azithromycin | Teva Pharmaceuticals USA, Inc. | ANDA |
| 50111-789 | Azithromycin | Azithromycin | Teva Pharmaceuticals USA, Inc. | ANDA |
| 54348-857 | Azithromycin | AZITHROMYCIN MONOHYDRATE | PharmPak, Inc. | ANDA |
| 55150-174 | Azithromycin | Azithromycin | Eugia US LLC | ANDA |
| 55695-002 | Azithromycin | Azithromycin | STATE HEALTH SERVICES, TEXAS DEPARTMENT OF | ANDA |
| 55695-003 | Azithromycin | Azithromycin | STATE HEALTH SERVICES, TEXAS DEPARTMENT OF | ANDA |
| 62135-704 | Azithromycin | Azithromycin | Chartwell RX, LLC | ANDA |
| 62135-705 | Azithromycin | Azithromycin | Chartwell RX, LLC | ANDA |
| 62756-512 | Azithromycin | Azithromycin | Sun Pharmaceutical Industries, Inc. | ANDA |
| 63187-007 | Azithromycin | Azithromycin | Proficient Rx LP | ANDA |
| 63187-093 | Azithromycin | Azithromycin | Proficient Rx LP | ANDA |
| 63187-189 | Azithromycin | Azithromycin | Proficient Rx LP | ANDA |
| 63323-398 | Azithromycin | AZITHROMYCIN MONOHYDRATE | Fresenius Kabi USA, LLC | ANDA |
| 68071-1527 | Azithromycin | Azithromycin | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3897 | AZITHROMYCIN | azithromycin | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-4773 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4795 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5035 | AZITHROMYCIN | AZITHROMYCIN | NuCare Pharmaceuticals,Inc. | ANDA |
| 68083-199 | Azithromycin monohydrate | Azithromycin monohydrate | Gland Pharma Limited | ANDA |
| 68788-7549 | AZITHROMYCIN | AZITHROMYCIN | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-8675 | Azithromycin | Azithromycin | Preferred Pharmaceuticals Inc. | ANDA |
| 70095-025 | Azithromycin monohydrate | Azithromycin monohydrate | Sun Pharmaceutical Industries Limited | ANDA |
| 70518-0599 | Azithromycin | Azithromycin | REMEDYREPACK INC. | ANDA |
| 70518-0784 | Azithromycin | Azithromycin | REMEDYREPACK INC. | ANDA |
| 70860-100 | Azithromycin | azithromycin monohydrate | Athenex Pharmaceutical Division, LLC. | ANDA |
| 70860-125 | Azithromycin | azithromycin monohydrate | Athenex Pharmaceutical Division, LLC. | ANDA |
| 71205-253 | AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | ANDA |
| 71205-566 | AZITHROMYCIN | AZITHROMYCIN | Proficient Rx LP | ANDA |
| 72189-314 | AZITHROMYCIN | AZITHROMYCIN | DirectRx | ANDA |
| 76420-006 | Azithromycin | Azithromycin | Asclemed USA, Inc. | ANDA |
| 76420-403 | Azithromycin | Azithromycin | ASCLEMED USA INC. | ANDA |
| 76420-589 | Azithromycin | Azithromycin | Asclemed USA, Inc. | ANDA |
| 80425-0219 | Azithromycin | Azithromycin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 82584-307 | AZASITE | azithromycin monohydrate | Thea Pharma Inc. | NDA |
| 85766-007 | Azithromycin | Azithromycin | Sportpharm LLC | ANDA |
| 85766-077 | Azithromycin | Azithromycin | Sportpharm LLC | ANDA |
| 0093-7147 | Azithromycin | Azithromycin | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-7148 | Azithromycin | Azithromycin Monohydrate | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-7149 | Azithromycin | Azithromycin Monohydrate | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0527-2370 | azithromycin | AZITHROMYCIN MONOHYDRATE | Lannett Company, Inc. | ANDA |
| 0527-2381 | azithromycin | AZITHROMYCIN MONOHYDRATE | Lannett Company, Inc. | ANDA |
| 0527-2395 | azithromycin | AZITHROMYCIN MONOHYDRATE | Lannett Company, Inc. | ANDA |
| 0781-1496 | Azithromycin | Azithromycin | Sandoz Inc | ANDA |
| 0781-1497 | Azithromycin | Azithromycin | Sandoz Inc | ANDA |
| 0781-1941 | Azithromycin | Azithromycin | Sandoz Inc | ANDA |
| 0781-5776 | Azithromycin | Azithromycin | Sandoz Inc | ANDA |
| 0781-5789 | Azithromycin | Azithromycin | Sandoz Inc | ANDA |
| 0781-5793 | Azithromycin | Azithromycin | Sandoz Inc | ANDA |
| 0781-8089 | Azithromycin | Azithromycin | Sandoz Inc | ANDA |
| 0781-8090 | Azithromycin | Azithromycin | Sandoz Inc | ANDA |
| 0781-8091 | Azithromycin | Azithromycin | Sandoz Inc | ANDA |
| 0904-6708 | azithromycin monohydrate | azithromycin monohydrate | Major Pharmaceuticals | ANDA |
| 0904-6909 | azithromycin monohydrate | azithromycin monohydrate | Major Pharmaceuticals | ANDA |
| 17478-307 | AzaSITE | Azithromycin Monohydrate | Akorn | NDA |
| 21695-548 | Azithromycin | Azithromycin monohydrate | Rebel Distributors Corp. | ANDA |
| 21695-549 | Azithromycin | Azithromycin monohydrate | Rebel Distributors Corp. | ANDA |
| 25021-112 | Azithromycin | azithromycin | Sagent Pharmaceuticals | ANDA |
| 33261-139 | Azithromycin | Azithromycin | Aidarex Pharmaceuticals LLC | ANDA |
| 35356-199 | Azithromycin | Azithromycin | Lake Erie Medical DBA Quality Care Products LLC | ANDA |