The short version
8 companies supply this market — a reasonable cushion if one runs into trouble.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Methylene Blue
Methylene Blue · METHYLENE BLUE 50 mg/10mL · Injection · Intravenous · Xiromed, Llc
NDC 70700-0328-24 · 5 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.
Estimated fill cost
WAC per package, as filed
$500.00
Reported to Texas DSHS · 2026 annual filing · Xiromed, LLC
Manufacturer list price as filed — not what pharmacies actually pay after discounts.
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
- ANDA219363
- TE code
- AP
- Approval date
- Jul 30, 2025
- Patents / exclusivity
- None on file
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
No enforcement reports list this package NDC.
Manufacturers of Methylene Blue (Injection)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| American Regent, Inc. | METHYLENE BLUE 5 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Bpi Labs Llc | METHYLENE BLUE 10 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Zydus Lifesciences Limited | METHYLENE BLUE 5 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Zydus Pharmaceuticals USA Inc. | METHYLENE BLUE 5 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| Chengdu Shuode Pharmaceutical Co., Ltd | METHYLENE BLUE 50 mg/10mL | Jul 15, 2026 | Sep 2, 2026 |
| Glenmark Pharmaceuticals Inc., Usa | METHYLENE BLUE 50 mg/10mL | Jul 15, 2026 | Sep 2, 2026 |
| Meitheal Pharmaceuticals Inc. | METHYLENE BLUE 5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Xiromed, Llc | METHYLENE BLUE 50 mg/10mL | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Lifesciences Limited | METHYLENE BLUE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Zydus Pharmaceuticals USA Inc. | METHYLENE BLUE 10 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Methylene Blue — NDC 70700-0328-24," retrieved September 3, 2026, https://drugdashboards.com/drug/70700032824.
Free to cite with attribution — see how the data is put together.