Drug
Who makes ibuprofen?
54 companies list ibuprofen as a human prescription drug, including under the names Caldolor, IBU, IBUPAK. Forms: injection; kit; suspension; tablet; tablet, film coated. 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 ibuprofen
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| NuCare Pharmaceuticals,Inc.United States | suspension; tablet; tablet, film coated | ANDAANDA071268, ANDA075682, ANDA078329 | 31 | 1 |
| International Medication Systems, Ltd.United States | tablet; tablet, film coated | ANDAANDA078329, ANDA078558, ANDA091625 | 28 | 3 |
| Aphena Pharma Solutions - Tennessee, LLC | tablet; tablet, film coated | ANDAANDA075682, ANDA078329, ANDA078558 | 19 | 0 |
| Bryant Ranch PrepackUnited States | tablet; tablet, film coated | ANDAANDA075682, ANDA078329, ANDA078558 | 18 | 1 |
| Proficient Rx LPUnited States | suspension; tablet; tablet, film coated | ANDAANDA074978, ANDA075682, ANDA076925 | 17 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | tablet, film coated | ANDAANDA078329, ANDA090796, ANDA091625 | 16 | 1 |
| RemedyRepack, IncUnited States | suspension; tablet; tablet, film coated | ANDAANDA078329, ANDA090796, ANDA091625 | 15 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet; tablet, film coated | ANDAANDA075682, ANDA078329, ANDA202413 | 13 | 1 |
| Advanced Rx of Tennessee, LLC | tablet; tablet, film coated | ANDAANDA078329, ANDA078558, ANDA090796 | 8 | 0 |
| Strides Pharma Science LimitedIndia | suspension; tablet, film coated | ANDAANDA078329, ANDA215311 | 7 | 5 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | tablet; tablet, film coated | ANDAANDA078329, ANDA202413, ANDA213794 | 7 | 1 |
| Northwind Health Company, LLCUnited States | tablet, film coated | ANDAANDA090796, ANDA091625 | 7 | 1 |
| Amneal Pharmaceuticals of New York, LLCIndia | tablet | ANDAANDA071334, ANDA071335, ANDA071935 | 6 | 14 |
| Direct RxUnited States | tablet; tablet, film coated | ANDAANDA078329, ANDA090796, ANDA213794 | 6 | 1 |
| St. Mary's Medical Park PharmacyUnited States | tablet; tablet, film coated | ANDAANDA078329, ANDA090796, ANDA202413 | 6 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet; tablet, film coated | ANDAANDA071268, ANDA075682 | 6 | 0 |
| Westminster Pharmaceuticals, LLC | tablet, film coated | ANDAANDA202413, ANDA215318 | 6 | 0 |
| Granules Pharmaceuticals Inc.India | tablet, film coated | ANDAANDA091625 | 5 | 8 |
| ASCEND Therapeutics US, LLC | tablet, film coated | ANDAANDA091625, ANDA214699 | 5 | 0 |
| Cardinal Health 418, Inc.United States | tablet; tablet, film coated | ANDAANDA075682, ANDA078558 | 4 | 34 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA075682 | 4 | 1 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA078558 | 3 | 5 |
| MARKSANS PHARMA LIMITEDIndia | tablet | ANDAANDA090796 | 3 | 2 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet, film coated | ANDAANDA090796, ANDA091625 | 3 | 1 |
| AiPing Pharmaceutical, Inc.United States | tablet, film coated | ANDAANDA202413 | 3 | 1 |
| Amneal Ireland LimitedIreland | tablet | ANDAANDA078558 | 3 | 1 |
| Coupler LLCUnited States | tablet; tablet, film coated | ANDAANDA202413, ANDA213794 | 3 | 1 |
| Florida Pharmaceutical Products LLCUnited States | tablet, film coated | ANDAANDA071268 | 3 | 1 |
| HAWAII REPACK INCUnited States | tablet | ANDAANDA213794 | 3 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet, film coated | ANDAANDA078329 | 3 | 1 |
| PharmPak, Inc.United States | tablet, film coated | ANDAANDA091625 | 3 | 1 |
| RedPharm DrugUnited States | tablet, film coated | ANDAANDA202413 | 3 | 1 |
| Skya Health, LLCUnited States | tablet | ANDAANDA090796 | 3 | 1 |
| Time Cap Laboratories, Inc.United States | tablet, film coated | ANDAANDA090796 | 3 | 1 |
| Amneal Pharmaceuticals NY LLC | tablet, film coated | ANDAANDA078329 | 3 | 0 |
| Chartwell RX, LLC. | tablet, film coated | ANDAANDA202413 | 3 | 0 |
| Exelan Pharmaceuticals, Inc. | tablet, film coated | ANDAANDA091625 | 3 | 0 |
| Sportpharm LLC | tablet | ANDAANDA213794 | 3 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | suspension | ANDAANDA209204 | 2 | 13 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA213794 | 2 | 6 |
| PHOENIX RX LLCUnited States | tablet; tablet, film coated | ANDAANDA078558, ANDA202413 | 2 | 1 |
| QPharma IncUnited States | tablet, film coated | ANDAANDA090796, ANDA091625 | 2 | 1 |
| Unit Dose Solutions, Inc.United States | tablet; tablet, film coated | ANDAANDA091625, ANDA213794 | 2 | 1 |
| Cumberland Pharmaceuticals Inc. | injection | NDANDA022348 | 2 | 0 |
| Legacy Pharmaceutical Packaging, LLC | tablet, film coated | ANDAANDA091625 | 2 | 0 |
| Northstar Rx, LLC, | tablet | ANDAANDA213794 | 2 | 0 |
| Quality Care Products, LLC | tablet | ANDAANDA213794 | 2 | 0 |
| SOLA Pharmaceuticals, LLC | tablet | ANDAANDA078329, ANDA202413 | 2 | 0 |
| Dr. Reddy's Laboratories LimitedIndia | tablet | ANDAANDA075682 | 1 | 15 |
| Padagis Israel Pharmaceuticals LtdUnited States | suspension | ANDAANDA076925 | 1 | 2 |
| PureTek CorporationUnited States | kit | UNAPPROVED DRUG OTHER | 1 | 2 |
| Actavis LLCUnited States | suspension | ANDAANDA074978 | 1 | 1 |
| Boswell Pharmacy Services LLCUnited States | tablet | ANDAANDA078558 | 1 | 1 |
| Brisk Pharmaceuticals | tablet, film coated | ANDAANDA202413 | 1 | 0 |
Bulk ingredient listings
- BASF CorporationUnited States · 4 NDC
- ASCLEMED USA INC. DBA ENOVACHEMUnited States · 3 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 3 NDC
- SI Group, IncUnited States · 3 NDC
- Shandong Xinhua Pharmaceutical Company LimitedChina · 2 NDC
- Zibo Xinhua - Perrigo Pharmaceutical Co., LtdChina · 2 NDC
- Hubei Biocause Heilen Pharmaceutical Co., LtdChina · 1 NDC
- IOL Chemicals and Pharmaceuticals Ltd.India · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- LNK International, Inc.United States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- SMS Pharmaceuticals LimitedIndia · 1 NDC
- SOLARA ACTIVE PHARMA SCIENCES LIMITEDIndia · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
- Strides Shasun Limited · 1 NDC
Orange Book patents
10 unexpired patents list ibuprofen as the active ingredient, expiring between Sept 2029 and Mar 2032. Application holder: APOTEX INC.
Enquiry
Common questions
- Who makes ibuprofen?
- 54 companies list ibuprofen as a human prescription drug in the openFDA NDC Directory, led by NuCare Pharmaceuticals,Inc., International Medication Systems, Ltd., Aphena Pharma Solutions - Tennessee, LLC, Bryant Ranch Prepack, Proficient Rx LP. 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 Caldolor?
- 52 companies list ibuprofen 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 ibuprofen active ingredient?
- 15 companies list ibuprofen as a bulk ingredient, including BASF Corporation, ASCLEMED USA INC. DBA ENOVACHEM, Professional Compounding Centers of America dba PCCA, SI Group, Inc.