DrugDashboards

Methylene blue

Methylene blue · METHYLENE BLUE 5 mg/mL · Injection · Intravenous · Zydus Pharmaceuticals USA Inc.

NDC 70710-1838-05 · 5 VIAL in 1 CARTON / 10 mL in 1 VIAL · ANDA · View full market →

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.

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
$1,171.94
Reported to Texas DSHS · 2026 annual filing · Zydus Pharmaceuticals (USA) Inc

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

Medicaid spend (2025)

$1,000
12 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

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 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
ANDA215636
TE code
AP
Approval date
Dec 5, 2023
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)

LabelerStrengthFirst seenLast seen
American Regent, Inc.METHYLENE BLUE 5 mg/mLJul 15, 2026Sep 3, 2026
Bpi Labs LlcMETHYLENE BLUE 10 mg/mLJul 15, 2026Sep 3, 2026
Zydus Lifesciences LimitedMETHYLENE BLUE 5 mg/mLJul 15, 2026Sep 3, 2026
Zydus Pharmaceuticals USA Inc.METHYLENE BLUE 5 mg/mLJul 15, 2026Sep 3, 2026
Chengdu Shuode Pharmaceutical Co., LtdMETHYLENE BLUE 50 mg/10mLJul 15, 2026Sep 2, 2026
Glenmark Pharmaceuticals Inc., UsaMETHYLENE BLUE 50 mg/10mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.METHYLENE BLUE 5 mg/mLJul 15, 2026Sep 2, 2026
Xiromed, LlcMETHYLENE BLUE 50 mg/10mLJul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedMETHYLENE BLUE 10 mg/mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.METHYLENE BLUE 10 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Methylene blue — NDC 70710-1838-05," retrieved September 3, 2026, https://drugdashboards.com/drug/70710183805.

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