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.
Choletec
Mebrofenin · MEBROFENIN 45 mg/1 · Injection, Powder, Lyophilized, For Solution · Intravenous · Bracco Diagnostics Inc
NDC 00270-0083-20 · 10 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
Where it's made
- Eurofins Lancaster Laboratories, LLCUnited Statesanalysis
- analysis
- Jubilant HollisterStier LLCUnited Statesanalysis · manufacture
- SGS North America Inc.United Statesanalysis
- Sigma-Aldrich Production GmbHSwitzerlandapi manufacture
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 1 of 6 public criteria. Why that matters →
- Part D specialty tier
- Costs ≥ $950/fill
- Biologic (BLA)
- Injectable / infused
- Orphan-drug exclusivity
- REMS program
Regulatory
- Application
- NDA018963
- TE code
- AP
- Approval date
- Jan 21, 1987
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class III · TerminatedAug 14, 2012Bracco Diagnostic Inc — Presence of Particulate Matter; potential for charcoal particulates
Manufacturers of Mebrofenin (Injection, Powder, Lyophilized, For Solution)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Bracco Diagnostics Inc | MEBROFENIN 45 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Choletec — NDC 00270-0083-20," retrieved September 3, 2026, https://drugdashboards.com/drug/00270008320.
Free to cite with attribution — see how the data is put together.