Drug
Who makes spironolactone?
38 companies list spironolactone as a human prescription drug, including under the names Aldactone. Forms: suspension; tablet; tablet, coated; 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 spironolactone
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Bryant Ranch PrepackUnited States | tablet; tablet, film coated | ANDAANDA040424, ANDA089424, ANDA091426 | 34 | 1 |
| International Medication Systems, Ltd.United States | tablet; tablet, coated; tablet, film coated | ANDAANDA040750, ANDA089424, ANDA202187 | 13 | 3 |
| Proficient Rx LPUnited States | tablet; tablet, coated; tablet, film coated | ANDAANDA040750, ANDA089424, ANDA203253 | 13 | 1 |
| RemedyRepack, IncUnited States | tablet; tablet, coated; tablet, film coated | ANDAANDA040750, ANDA089424, ANDA202187 | 9 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet; tablet, coated; tablet, film coated | ANDAANDA040750, ANDA089424, ANDA203512 | 8 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet; tablet, coated; tablet, film coated | ANDAANDA040750, ANDA202187, ANDA203512 | 8 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, coated; tablet, film coated | ANDAANDA040750, ANDA203512 | 6 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet; tablet, film coated | ANDAANDA040424, ANDA089424, ANDA091426 | 6 | 0 |
| Camber Pharmaceuticals, Inc.United States | suspension; tablet, film coated | ANDAANDA217761, ANDA218085 | 4 | 1 |
| Northwind Health Company, LLCUnited States | tablet, film coated | ANDAANDA203512, ANDA205936 | 4 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet, coated; tablet, film coated | ANDAANDA040750, ANDA089424 | 4 | 1 |
| Amneal Pharmaceuticals of New York, LLCIndia | tablet | ANDAANDA091426 | 3 | 14 |
| Sun Pharmaceutical Industries LimitedIndia | tablet; tablet, film coated | ANDAANDA089424 | 3 | 13 |
| Zydus Lifesciences LimitedIndia | tablet, film coated | ANDAANDA205936 | 3 | 12 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA202187 | 3 | 6 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA205936 | 3 | 5 |
| Safecor Health, LLCUnited States | tablet, film coated | ANDAANDA040424 | 3 | 3 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | tablet, film coated | ANDAANDA203512 | 3 | 2 |
| Amneal Ireland LimitedIreland | tablet | ANDAANDA091426 | 3 | 1 |
| Coupler LLCUnited States | tablet, coated | ANDAANDA040750 | 3 | 1 |
| Direct RxUnited States | tablet, coated | ANDAANDA040750 | 3 | 1 |
| Oxford Pharmaceuticals, LLCUnited States | tablet, coated | ANDAANDA040750 | 3 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet | ANDAANDA219494 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet, film coated | ANDAANDA205936 | 3 | 1 |
| Jubilant Cadista Pharmacuticals Inc. | tablet, film coated | ANDAANDA203253 | 3 | 0 |
| Mylan Institutional Inc. | tablet, film coated | ANDAANDA040424 | 3 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA040424 | 3 | 0 |
| Northstar Rx, LLC, | tablet | ANDAANDA202187 | 3 | 0 |
| Pfizer Laboratories Div Pfizer Inc | tablet, film coated | NDANDA012151 | 3 | 0 |
| Cardinal Health 418, Inc.United States | tablet, film coated | ANDAANDA040424, ANDA205936 | 2 | 34 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | ANDAANDA202187 | 2 | 1 |
| QPharma IncUnited States | tablet; tablet, film coated | ANDAANDA091426, ANDA203253 | 2 | 1 |
| RedPharm DrugUnited States | tablet | ANDAANDA202187 | 2 | 1 |
| South Atlantic Corporation LLCUnited States | suspension | NDA AUTHORIZED GENERICNDA209478 | 2 | 1 |
| Padagis Israel Pharmaceuticals LtdUnited States | suspension | NDA AUTHORIZED GENERICNDA209478 | 1 | 2 |
| PharmPak, Inc.United States | tablet | ANDAANDA091426 | 1 | 1 |
| Amneal Pharmaceuticals NY LLC | suspension | ANDAANDA215572 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet, film coated | ANDAANDA205936 | 1 | 0 |
Bulk ingredient listings
- Dasami Lab Private LimitedIndia · 1 NDC
- EUROAPIFrance · 1 NDC
- Galenova IncCanada · 1 NDC
- Gedeon Richter Plc.Hungary · 1 NDC
- Henan Lihua Pharmaceutical Co LtdChina · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Pharma Source Direct, LLCUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Tianjin Jinjin Pharmaceuticals Co., Ltd.China · 1 NDC
- Tianjin Tianyao Pharmaceuticals Co., Ltd.China · 1 NDC
- Zhejiang Langhua Pharmaceutical Co. Ltd.China · 1 NDC
- Zhejiang Shenzhou Pharmaceutical Co., Ltd.China · 1 NDC
Orange Book patents
8 unexpired patents list spironolactone as the active ingredient, expiring between Oct 2036 and Oct 2036. Application holder: CMP DEVELOPMENT LLC.
Enquiry
Common questions
- Who makes spironolactone?
- 38 companies list spironolactone as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, International Medication Systems, Ltd., Proficient Rx LP, RemedyRepack, Inc, ASCLEMED USA INC. DBA ENOVACHEM. 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 Aldactone?
- 35 companies list spironolactone under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies spironolactone active ingredient?
- 13 companies list spironolactone as a bulk ingredient, including Dasami Lab Private Limited, EUROAPI, Galenova Inc, Gedeon Richter Plc..