Drug
Who makes pantoprazole sodium?
52 companies list pantoprazole sodium as a human prescription drug, including under the names Protonix Delayed-Release, Protonix I.V.. Forms: for suspension; granule, delayed release; injection, powder, for solution; injection, powder, lyophilized, for solution; tablet, delayed release. Routes: intravenous, 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 pantoprazole sodium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Cardinal Health 418, Inc.United States | injection, powder, for solution; injection, powder, lyophilized, for solution; tablet, delayed release | ANDA, NDAANDA078281, ANDA090074, ANDA090970 | 10 | 34 |
| Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.United States | granule, delayed release; injection, powder, for solution; tablet, delayed release | NDANDA020987, NDA020988, NDA022020 | 5 | 10 |
| International Medication Systems, Ltd.United States | tablet, delayed release | ANDAANDA090074, ANDA202038 | 4 | 3 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet, delayed release | ANDAANDA090970, ANDA202882 | 4 | 1 |
| Bryant Ranch PrepackUnited States | tablet, delayed release | ANDAANDA078281, ANDA090970, ANDA202038 | 4 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet, delayed release | ANDAANDA090074, ANDA202038 | 4 | 1 |
| Sun Pharmaceutical Industries LimitedIndia | granule, delayed release; injection, powder, lyophilized, for solution | ANDAANDA077674, ANDA204400, ANDA213725 | 3 | 13 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | for suspension; tablet, delayed release | ANDAANDA202038, ANDA217416 | 3 | 5 |
| RemedyRepack, IncUnited States | tablet, delayed release | ANDAANDA202038 | 3 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet, delayed release | ANDAANDA090074, ANDA202038 | 3 | 0 |
| Granules Pharmaceuticals Inc.India | tablet, delayed release | ANDAANDA217282 | 2 | 8 |
| Torrent Pharma, Inc.India | tablet, delayed release | ANDAANDA090074 | 2 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | injection, powder, lyophilized, for solution | NDANDA209463 | 2 | 4 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet, delayed release | ANDAANDA202038 | 2 | 1 |
| Camber Pharmaceuticals, Inc.United States | granule, delayed release; injection, powder, for solution | ANDAANDA213778, ANDA216139 | 2 | 1 |
| Coupler LLCUnited States | tablet, delayed release | ANDAANDA202038 | 2 | 1 |
| Golden State Medical Supply Inc.United States | tablet, delayed release | ANDAANDA078281 | 2 | 1 |
| HAWAII REPACK INCUnited States | tablet, delayed release | ANDAANDA202038 | 2 | 1 |
| Lannett Company, LLCUnited States | tablet, delayed release | ANDAANDA078281 | 2 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, delayed release | ANDAANDA090970, ANDA202038 | 2 | 1 |
| Northwind Health Company, LLCUnited States | tablet, delayed release | ANDAANDA202038 | 2 | 1 |
| QPharma IncUnited States | tablet, delayed release | ANDAANDA090970, ANDA202038 | 2 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet, delayed release | ANDAANDA219087 | 2 | 1 |
| Unit Dose Solutions, Inc.United States | tablet, delayed release | ANDAANDA202038 | 2 | 1 |
| Advanced Rx of Tennessee, LLC | tablet, delayed release | ANDAANDA202038, ANDA205119 | 2 | 0 |
| AvPAK | tablet, delayed release | ANDAANDA078281 | 2 | 0 |
| Chartwell RX, LLC. | tablet, delayed release | ANDAANDA078281 | 2 | 0 |
| Mylan Pharmaceuticals, Inc. | tablet, delayed release | ANDAANDA090970 | 2 | 0 |
| Northstar Rx, LLC, | injection, powder, for solution; tablet, delayed release | ANDAANDA202038, ANDA215860 | 2 | 0 |
| Aurobindo Pharma LimitedIndia | granule, delayed release | ANDAANDA217923 | 1 | 6 |
| Fresenius Kabi USA, LLCUnited States | injection, powder, lyophilized, for solution | ANDAANDA216021 | 1 | 6 |
| Sandoz Industrial Products S.AAustria | injection, powder, for solution | ANDAANDA209524 | 1 | 5 |
| GLAND PHARMA LIMITEDIndia | injection, powder, lyophilized, for solution | ANDAANDA204400 | 1 | 4 |
| Safecor Health, LLCUnited States | tablet, delayed release | ANDAANDA090970 | 1 | 3 |
| Ajanta Pharma LimitedIndia | for suspension | ANDAANDA217416 | 1 | 2 |
| Civica, Inc. dba CivicaRxUnited States | injection, powder, lyophilized, for solution | NDANDA209463 | 1 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, delayed release | ANDAANDA078281 | 1 | 1 |
| Piramal Critical Care IncUnited States | injection, powder, for solution | ANDAANDA214680 | 1 | 1 |
| Proficient Rx LPUnited States | tablet, delayed release | ANDAANDA078281 | 1 | 1 |
| RedPharm DrugUnited States | tablet, delayed release | ANDAANDA202038 | 1 | 1 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet, delayed release | ANDAANDA078281 | 1 | 0 |
| BE Pharmaceuticals Inc. | injection, powder, for solution | ANDAANDA216171 | 1 | 0 |
| Burel Pharmaceuticals, LLC | tablet, delayed release | ANDAANDA202038 | 1 | 0 |
| Devatis, Inc. | injection, powder, for solution | ANDAANDA215074 | 1 | 0 |
| Edenbridge Pharmaceuticals LLC. | granule, delayed release | ANDAANDA216247 | 1 | 0 |
| Eugia US LLC | injection, powder, for solution | ANDAANDA205675 | 1 | 0 |
| Meitheal Pharmaceuticals, Inc. | injection, powder, for solution | ANDAANDA215860 | 1 | 0 |
| Mylan Institutional Inc. | tablet, delayed release | ANDAANDA090970 | 1 | 0 |
| NorthStar RxLLC | granule, delayed release | ANDAANDA213725 | 1 | 0 |
| Novadoz Pharmaceuticals LLC | injection, powder, for solution | ANDAANDA216171 | 1 | 0 |
| Quality Care Products, LLC | tablet, delayed release | ANDAANDA202038 | 1 | 0 |
| Sagent Pharmaceuticals | injection, powder, lyophilized, for solution | ANDAANDA204400 | 1 | 0 |
Bulk ingredient listings
- AZICO BIOPHORE INDIA PRIVATE LIMITEDIndia · 1 NDC
- CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Hetero Drugs LimitedIndia · 1 NDC
- IOL Chemicals and Pharmaceuticals Ltd.India · 1 NDC
- Jubilant Biosys LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- MSN Life Sciences Private LimitedIndia · 1 NDC
- Metrochem API Private LimitedIndia · 1 NDC
- NATCO PHARMA LIMITEDIndia · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Pure and Cure Healthcare Private LimitedIndia · 1 NDC
- QUIMICA SINTETICA SASpain · 1 NDC
- SMS Pharmaceuticals LimitedIndia · 1 NDC
- Shouguang Fukang Pharmaceutical Co LtdChina · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Vasudha Pharma Chem LimitedIndia · 1 NDC
Orange Book patents
1 unexpired patent lists pantoprazole sodium as the active ingredient, expiring between Dec 2026 and Dec 2026. Application holder: WYETH PHARMACEUTICALS LLC.
Enquiry
Common questions
- Who makes pantoprazole sodium?
- 52 companies list pantoprazole sodium as a human prescription drug in the openFDA NDC Directory, led by Cardinal Health 418, Inc., Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., International Medication Systems, Ltd., ADVANCED RX PHARMACY OF TENNESSEE LLC, Bryant Ranch Prepack. 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 Protonix Delayed-Release?
- 49 companies list pantoprazole sodium under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies pantoprazole sodium active ingredient?
- 18 companies list pantoprazole sodium as a bulk ingredient, including AZICO BIOPHORE INDIA PRIVATE LIMITED, CIPLA PHARMACEUTICALS LIMITED, Dr. Reddy's Laboratories Limited, Hetero Drugs Limited.