Quick answers
- What is Pancreaze?
- Pancreaze is a brand name of Pancrelipase, a prescription medicine. The FDA NDC Directory lists 6 Pancreaze products in 6 strengths and forms.
- Who makes Pancreaze?
- Vivus Inc holds the FDA application for Pancreaze (BLA022523, approved April 12, 2010).
- Is there a generic or store brand of Pancreaze?
- Other products of Pancrelipase are listed with the FDA, but none in exactly the same strength and form as a Pancreaze product.
- Has Pancreaze been recalled?
- FDA enforcement reports list 1 recall of Pancreaze products; the newest started June 23, 2023. A recall usually concerns specific lots, not every product.
What Pancreaze is
Each Pancreaze product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Pancrelipase · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| pancrelipase amylase 149900 USP units · pancrelipase lipase 37000 USP units · pancrelipase protease 97300 USP units capsule, delayed release (oral) | Pancreaze | None listed | DailyMed |
| pancrelipase amylase 15200 USP units · pancrelipase lipase 2600 USP units · pancrelipase protease 8800 USP units capsule, delayed release (oral) | Pancreaze | None listed | DailyMed |
| pancrelipase amylase 24600 USP units · pancrelipase lipase 4200 USP units · pancrelipase protease 14200 USP units capsule, delayed release (oral) | Pancreaze | None listed | DailyMed |
| pancrelipase amylase 61500 USP units · pancrelipase lipase 10500 USP units · pancrelipase protease 35500 USP units capsule, delayed release (oral) | Pancreaze | None listed | DailyMed |
| pancrelipase amylase 83900 USP units · pancrelipase lipase 21000 USP units · pancrelipase protease 54700 USP units capsule, delayed release (oral) | Pancreaze | None listed | DailyMed |
| pancrelipase amylase 98400 USP units · pancrelipase lipase 16800 USP units · pancrelipase protease 56800 USP units capsule, delayed release (oral) | Pancreaze | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Pancrelipase →
FDA approval
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| BLA022523 | Vivus Inc | April 12, 2010 | 6 |
Companies that list Pancreaze
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Pancreaze products.
- Vivus LLC6 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 23, 2023 · Class III · Ongoing · D-0896-2023
Failed Stability Specifications
PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10, — Vivus, Inc.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.