DrugDashboards

Norepinephrine Bitartrate

Norepinephrine Bitartrate · NOREPINEPHRINE BITARTRATE 1 mg/mL · Injection, Solution, Concentrate · Intravenous · Sun Pharmaceutical Industries, Inc.

NDC 47335-0615-44 · 10 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply.

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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
$87.40
Reported to Texas DSHS · 2026 annual filing · Sun Pharma

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

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
ANDA211980
TE code
Approval date
Jan 29, 2021
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class III · TerminatedMar 29, 2023
    SUN PHARMACEUTICAL INDUSTRIES INCFailed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.

Manufacturers of Norepinephrine Bitartrate (Injection, Solution, Concentrate)

LabelerStrengthFirst seenLast seen
Hospira, Inc.NOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 3, 2026
Mylan Institutional LLCNOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 3, 2026
Amneal Pharmaceuticals LLCNOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
Anthea Pharma Private LimitedNOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
Biocon Pharma Inc.NOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
Breckenridge Pharmaceutical, Inc.NOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.NOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
Civica, Inc.NOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals Inc.NOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCNOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
Sandoz IncNOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.NOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Norepinephrine Bitartrate — NDC 47335-0615-44," retrieved September 3, 2026, https://drugdashboards.com/drug/47335061544.

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