Drug
Who makes sertraline hydrochloride?
45 companies list sertraline hydrochloride as a human prescription drug, including under the names Zoloft. Forms: capsule; solution; solution, concentrate; tablet; tablet, film coated. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing sertraline hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | tablet; tablet, film coated | ANDAANDA077206, ANDA077670, ANDA078403 | 22 | 3 |
| Bryant Ranch PrepackUnited States | solution; tablet; tablet, film coated | ANDAANDA076934, ANDA077206, ANDA077397 | 16 | 1 |
| RemedyRepack, IncUnited States | tablet; tablet, film coated | ANDAANDA077206, ANDA077397, ANDA077670 | 10 | 1 |
| Proficient Rx LPUnited States | tablet; tablet, film coated | ANDAANDA077206, ANDA077397, ANDA077670 | 9 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet; tablet, film coated | ANDAANDA077206, ANDA077397, ANDA202825 | 8 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA077206, ANDA077670, ANDA078403 | 8 | 1 |
| Lupin LimitedIndia | tablet, film coated | ANDAANDA077670 | 6 | 14 |
| Coupler LLCUnited States | tablet; tablet, film coated | ANDAANDA077206, ANDA077397, ANDA077670 | 6 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet; tablet, film coated | ANDAANDA077206, ANDA077397, ANDA214790 | 6 | 1 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | capsule; tablet | ANDAANDA077397, ANDA218853 | 5 | 7 |
| Cardinal Health 418, Inc.United States | tablet; tablet, film coated | ANDAANDA077397, ANDA077670 | 4 | 34 |
| Viatris Inc.India | solution, concentrate; tablet, film coated | NDANDA019839, NDA020990 | 4 | 18 |
| Northwind Health Company, LLCUnited States | tablet; tablet, film coated | ANDAANDA077206, ANDA077397, ANDA078403 | 4 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet, film coated | ANDAANDA077206, ANDA078403, ANDA202825 | 4 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet; tablet, film coated | ANDAANDA077206, ANDA077397, ANDA202825 | 4 | 0 |
| Northstar Rx, LLC, | solution; tablet, film coated | ANDAANDA077206, ANDA078861 | 4 | 0 |
| Granules Pharmaceuticals Inc.India | tablet, film coated | ANDAANDA078403 | 3 | 8 |
| Aurobindo Pharma LimitedIndia | solution, concentrate; tablet, film coated | ANDAANDA077206, ANDA078861 | 3 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA077397 | 3 | 5 |
| ScieGen Pharmaceuticals India Private LimitedIndia | tablet, film coated | ANDAANDA076442 | 3 | 3 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet, film coated | ANDAANDA202825 | 3 | 2 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet, film coated | ANDAANDA077206 | 3 | 1 |
| Ascent Pharmaceuticals IncUnited States | tablet | ANDAANDA214790 | 3 | 1 |
| Camber Pharmaceuticals, Inc.United States | tablet | ANDAANDA214790 | 3 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, film coated | ANDAANDA077670 | 3 | 1 |
| Unit Dose Solutions, Inc.United States | tablet, film coated | ANDAANDA077206, ANDA077670 | 3 | 1 |
| XLCare Pharmaceuticals Inc.United States | tablet | ANDAANDA214790 | 3 | 1 |
| AvPAK | tablet, film coated | ANDAANDA077670 | 3 | 0 |
| Legacy Pharmaceutical Packaging, LLC | tablet | ANDAANDA077397 | 3 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA077670 | 3 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | capsule | ANDAANDA218712 | 2 | 15 |
| Zydus Lifesciences LimitedIndia | capsule | ANDAANDA220275 | 2 | 12 |
| Biocon Biologics LimitedIndia | capsule | ANDAANDA218342 | 2 | 9 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet, film coated | ANDAANDA077206 | 2 | 1 |
| ANI Pharmaceuticals, Inc.United States | capsule | ANDAANDA219714 | 2 | 1 |
| QPharma IncUnited States | tablet, film coated | ANDAANDA077206, ANDA202825 | 2 | 1 |
| UMEDICA LABORATORIES PRIVATE LIMITEDIndia | capsule | ANDAANDA218342 | 2 | 1 |
| Zydus Pharmaceuticals USA Inc.India | capsule | ANDAANDA220275 | 2 | 1 |
| Almatica Pharma Inc. | capsule | NDANDA215133 | 2 | 0 |
| Alvogen, Inc. | capsule | NDA AUTHORIZED GENERICNDA215133 | 2 | 0 |
| Quallent Pharmaceuticals Health, LLC | tablet, film coated | ANDAANDA077397 | 2 | 0 |
| Direct RxUnited States | tablet, film coated | ANDAANDA077206 | 1 | 1 |
| Rising Pharma Holdings, Inc.United States | solution, concentrate | ANDAANDA078861 | 1 | 1 |
| Mylan Pharmaceuticals, Inc. | solution, concentrate | NDA AUTHORIZED GENERICNDA020990 | 1 | 0 |
| Quality Care Products, LLC | tablet, film coated | ANDAANDA077206 | 1 | 0 |
Bulk ingredient listings
- Hetero Drugs LimitedIndia · 3 NDC
- Matrix Pharmacorp Private LimitedIndia · 3 NDC
- Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)India · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Chemeca Drugs Private LimitedIndia · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Pfizer IncUnited States · 1 NDC
- Symed Labs Limited · 1 NDC
- Wanbury LimitedIndia · 1 NDC
- Zhejiang Huahai Pharmaceutical Technology Co LtdChina · 1 NDC
Enquiry
Common questions
- Who makes sertraline hydrochloride?
- 45 companies list sertraline hydrochloride as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Bryant Ranch Prepack, RemedyRepack, Inc, Proficient Rx LP, PD-Rx Pharmaceuticals Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Zoloft?
- 41 companies list sertraline hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies sertraline hydrochloride active ingredient?
- 10 companies list sertraline hydrochloride as a bulk ingredient, including Hetero Drugs Limited, Matrix Pharmacorp Private Limited, Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.), Aurobindo Pharma Limited.