DrugDashboards

Pancreaze

PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE · PANCRELIPASE LIPASE 10500 [USP'U]/1; PANCRELIPASE AMYLASE 61500 [USP'U]/1; PANCRELIPASE PROTEASE 35500 [USP'U]/1 · Capsule, Delayed Release · Oral · Vivus Llc

NDC 62541-0403-10 · 1 BOTTLE, GLASS in 1 CARTON / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS · BLA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Part D plans paid (avg)$6.17per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$3.36per unitnegotiated price across 47 plans — before rebates · Apr 1, 2026

Medicare Part D

All Part D pricing →
ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$3.36per unit
middle half $3.30$3.45 · 47 plans · Apr 1, 2026
Est. net of rebates
$2.02–$2.52
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
1%of plans cover it
tier 3 · prior auth 2% · step therapy 0% · qty limit 0%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Estimated fill cost

WAC per package, as filed
$331.08
Reported to Texas DSHS · 2025 annual filing · Vivus Llc

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2022)

$389,612
706 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for pancrelipase lipase, pancrelipase protease, pancrelipase amylase (oral solid) in the next 90 days

sole-source market · price up 4% YoY

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 2 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 3 across plans
  • Costs ≥ $950/fill · avg $1,565.48 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA022523
TE code
Approval date
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · OngoingJun 23, 2023
    Vivus, Inc.Failed Stability Specifications

Manufacturers of PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, and PANCRELIPASE PROTEASE (Capsule, Delayed Release)

LabelerStrengthFirst seenLast seen
Vivus LlcPANCRELIPASE LIPASE 10500 [USP'U]/1; PANCRELIPASE AMYLASE 61500 [USP'U]/1; PANCRELIPASE PROTEASE 35500 [USP'U]/1Aug 26, 2026Sep 2, 2026
Vivus LlcPANCRELIPASE LIPASE 4200 [USP'U]/1; PANCRELIPASE AMYLASE 24600 [USP'U]/1; PANCRELIPASE PROTEASE 14200 [USP'U]/1Aug 26, 2026Sep 2, 2026
Vivus LlcPANCRELIPASE LIPASE 37000 [USP'U]/1; PANCRELIPASE AMYLASE 149900 [USP'U]/1; PANCRELIPASE PROTEASE 97300 [USP'U]/1Aug 26, 2026Sep 2, 2026
Vivus LlcPANCRELIPASE LIPASE 2600 [USP'U]/1; PANCRELIPASE AMYLASE 15200 [USP'U]/1; PANCRELIPASE PROTEASE 8800 [USP'U]/1Aug 26, 2026Sep 2, 2026
Vivus LlcPANCRELIPASE LIPASE 21000 [USP'U]/1; PANCRELIPASE AMYLASE 83900 [USP'U]/1; PANCRELIPASE PROTEASE 54700 [USP'U]/1Aug 26, 2026Sep 2, 2026
Vivus LlcPANCRELIPASE LIPASE 16800 [USP'U]/1; PANCRELIPASE AMYLASE 98400 [USP'U]/1; PANCRELIPASE PROTEASE 56800 [USP'U]/1Aug 26, 2026Sep 2, 2026
Vivus LlcPANCRELIPASE LIPASE 98400 [USP'U]/1; PANCRELIPASE AMYLASE 16800 [USP'U]/1; PANCRELIPASE PROTEASE 56800 [USP'U]/1Jul 22, 2026Aug 19, 2026
Vivus LlcPANCRELIPASE LIPASE 149900 [USP'U]/1; PANCRELIPASE AMYLASE 37000 [USP'U]/1; PANCRELIPASE PROTEASE 97300 [USP'U]/1Jul 22, 2026Aug 19, 2026
Vivus LlcPANCRELIPASE LIPASE 15200 [USP'U]/1; PANCRELIPASE AMYLASE 2600 [USP'U]/1; PANCRELIPASE PROTEASE 8800 [USP'U]/1Jul 22, 2026Aug 19, 2026
Vivus LlcPANCRELIPASE LIPASE 24600 [USP'U]/1; PANCRELIPASE AMYLASE 4200 [USP'U]/1; PANCRELIPASE PROTEASE 14200 [USP'U]/1Jul 22, 2026Aug 19, 2026
Vivus LlcPANCRELIPASE LIPASE 61500 [USP'U]/1; PANCRELIPASE AMYLASE 10500 [USP'U]/1; PANCRELIPASE PROTEASE 35500 [USP'U]/1Jul 22, 2026Aug 19, 2026
Vivus LlcPANCRELIPASE LIPASE 83900 [USP'U]/1; PANCRELIPASE AMYLASE 21000 [USP'U]/1; PANCRELIPASE PROTEASE 54700 [USP'U]/1Jul 22, 2026Aug 19, 2026
Vivus LlcPANCRELIPASE AMYLASE 61500 [USP'U]/1; PANCRELIPASE LIPASE 10500 [USP'U]/1; PANCRELIPASE PROTEASE 35500 [USP'U]/1Jul 15, 2026Jul 15, 2026
Vivus LlcPANCRELIPASE AMYLASE 24600 [USP'U]/1; PANCRELIPASE LIPASE 4200 [USP'U]/1; PANCRELIPASE PROTEASE 14200 [USP'U]/1Jul 15, 2026Jul 15, 2026
Vivus LlcPANCRELIPASE AMYLASE 15200 [USP'U]/1; PANCRELIPASE LIPASE 2600 [USP'U]/1; PANCRELIPASE PROTEASE 8800 [USP'U]/1Jul 15, 2026Jul 15, 2026
Vivus LlcPANCRELIPASE AMYLASE 98400 [USP'U]/1; PANCRELIPASE LIPASE 16800 [USP'U]/1; PANCRELIPASE PROTEASE 56800 [USP'U]/1Jul 15, 2026Jul 15, 2026
Vivus LlcPANCRELIPASE AMYLASE 83900 [USP'U]/1; PANCRELIPASE LIPASE 21000 [USP'U]/1; PANCRELIPASE PROTEASE 54700 [USP'U]/1Jul 15, 2026Jul 15, 2026
Vivus LlcPANCRELIPASE AMYLASE 149900 [USP'U]/1; PANCRELIPASE LIPASE 37000 [USP'U]/1; PANCRELIPASE PROTEASE 97300 [USP'U]/1Jul 15, 2026Jul 15, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Pancreaze — NDC 62541-0403-10," retrieved September 3, 2026, https://drugdashboards.com/drug/62541040310.

Free to cite with attribution — see how the data is put together.