The short version
5 companies supply this market — a reasonable cushion if one runs into trouble.
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gadobutrol
gadobutrol · GADOBUTROL 604.72 mg/mL · Injection · Intravenous · Viwit Pharmaceutical Co., Ltd.
NDC 42337-0006-02 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE · ANDA · 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.
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
- ANDA219287
- TE code
- AP
- Approval date
- Jun 11, 2026
- Patents / exclusivity
- None on file
Shortage history
- Planned discontinuation — Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-02)Jun 30, 2026
- Planned discontinuation — Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-07)Jun 30, 2026
- Planned discontinuation — Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-10)Jun 30, 2026
- Planned discontinuation — Gadobutrol, Injection, 604.72 mg/mL (NDC 65219-281-15)Jun 30, 2026
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of gadobutrol (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Slate Run Pharmaceuticals, LLC | GADOBUTROL 604.72 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Zydus Pharmaceuticals USA Inc. | GADOBUTROL 604.72 mg/mL | Jul 25, 2026 | Sep 3, 2026 |
| Fresenius Kabi USA, LLC | GADOBUTROL 604.72 mg/mL | Jul 15, 2026 | Aug 31, 2026 |
| Viwit Pharmaceutical Co., Ltd. | GADOBUTROL 604.72 mg/mL | Jul 25, 2026 | Aug 31, 2026 |
| Bayer HealthCare Pharmaceuticals Inc. | GADOBUTROL 604.72 mg/mL | Jul 15, 2026 | Aug 28, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "gadobutrol — NDC 42337-0006-02," retrieved September 3, 2026, https://drugdashboards.com/drug/42337000602.
Free to cite with attribution — see how the data is put together.