Drug
Who makes leucovorin calcium?
17 companies list leucovorin calcium as a human prescription drug, including under the names VYKOURA. Forms: injection; injection, powder, lyophilized, for solution; injection, powder, lyophilized, for suspension; tablet. Routes: intramuscular, 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 leucovorin calcium
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | injection, powder, lyophilized, for solution; tablet | ANDAANDA040056, ANDA040335, ANDA072733 | 10 | 4 |
| BluePoint Laboratories Inc. | injection, powder, lyophilized, for solution | ANDAANDA040056, ANDA040335, ANDA089717 | 6 | 0 |
| Slate Run Pharmaceuticals, LLCUnited States | injection, powder, lyophilized, for solution | ANDAANDA217021 | 5 | 1 |
| Meitheal Pharmaceuticals, Inc. | injection, powder, lyophilized, for solution | ANDAANDA216590 | 5 | 0 |
| Sagent Pharmaceuticals | injection, powder, lyophilized, for solution | ANDAANDA200753, ANDA200855, ANDA209110 | 5 | 0 |
| Epic Laboratories, LLCUnited States | tablet | ANDAANDA074544 | 4 | 3 |
| Leading Pharma, LLCUnited States | tablet | ANDAANDA213929 | 4 | 1 |
| Ingenus Pharmaceuticals, LLC | tablet | ANDAANDA211132 | 4 | 0 |
| Fresenius Kabi USA, LLCUnited States | injection; injection, powder, lyophilized, for solution | ANDAANDA040258, ANDA040286, ANDA207226 | 3 | 6 |
| Avyxa GmbHSwitzerland | injection | NDANDA220406 | 3 | 1 |
| Mylan Institutional Inc. | injection, powder, lyophilized, for suspension | ANDAANDA203800 | 3 | 0 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet | ANDAANDA071198, ANDA071199 | 2 | 6 |
| Glenmark Pharmaceuticals Inc., USAIndia | injection, powder, lyophilized, for solution | ANDAANDA218200 | 1 | 9 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA071199 | 1 | 5 |
| GLAND PHARMA LIMITEDIndia | injection, powder, lyophilized, for solution | ANDAANDA218200 | 1 | 4 |
| Proficient Rx LPUnited States | tablet | ANDAANDA213929 | 1 | 1 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA211132 | 1 | 0 |
Bulk ingredient listings
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- Spectrum Pharmaceuticals, Inc.United States · 2 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Cerbios-Pharma SASwitzerland · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- GMT Fine Chemicals SASwitzerland · 1 NDC
- Huzhou Zhanwang Pharmaceutical Co., Ltd.China · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- MOLCLONE LABS PRIVATE LIMITEDIndia · 1 NDC
- Qingdao Biopeptek Co LtdChina · 1 NDC
- Willow Birch Pharma, LLCUnited States · 1 NDC
Orange Book patents
1 unexpired patent lists leucovorin calcium as the active ingredient, expiring between Dec 2044 and Dec 2044. Application holder: AVYXA HOLDINGS LLC.
Enquiry
Common questions
- Who makes leucovorin calcium?
- 17 companies list leucovorin calcium as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., BluePoint Laboratories Inc., Slate Run Pharmaceuticals, LLC, Meitheal Pharmaceuticals, Inc., Sagent Pharmaceuticals. 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 VYKOURA?
- 16 companies list leucovorin calcium 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 leucovorin calcium active ingredient?
- 12 companies list leucovorin calcium as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, Spectrum Pharmaceuticals, Inc., AX Pharmaceutical Corp, Cerbios-Pharma SA.