DrugDashboards

Norepinephrine Bitartrate

norepinephrine bitartrate · NOREPINEPHRINE BITARTRATE 16 mg/250mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation

NDC 00338-0116-20 · 20 BAG in 1 CARTON / 250 mL in 1 BAG · NDA · View full market →

The short version

4 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
$66.70
Reported to Texas DSHS · 2026 annual filing · Baxter Healthcare Corporation

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
NDA214313
TE code
AP
Approval date
Jan 15, 2021
Patents / exclusivity
5 patents, 0 exclusivities
TypeNumber / codeExpires
patent12097170Mar 8, 2041
patent12097170Mar 8, 2041
patent12097170Mar 8, 2041
patent12290494Mar 8, 2041
patent12290494Mar 8, 2041

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJan 23, 2024
    Baxter Healthcare Corporation — Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.

Manufacturers of norepinephrine bitartrate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Baxter Healthcare CorporationNOREPINEPHRINE BITARTRATE 4 mg/250mLJul 15, 2026Sep 3, 2026
Baxter Healthcare CorporationNOREPINEPHRINE BITARTRATE 8 mg/250mLJul 15, 2026Sep 3, 2026
Avenacy, LLCNOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
Sagent PharmaceuticalsNOREPINEPHRINE BITARTRATE 1 mg/mLJul 15, 2026Sep 2, 2026
WG Critical Care, LLCNOREPINEPHRINE BITARTRATE .128 mg/mLJul 15, 2026Sep 2, 2026
WG Critical Care, LLCNOREPINEPHRINE BITARTRATE .016 mg/mLJul 15, 2026Sep 2, 2026
WG Critical Care, LLCNOREPINEPHRINE BITARTRATE .064 mg/mLJul 15, 2026Sep 2, 2026
WG Critical Care, LLCNOREPINEPHRINE BITARTRATE .032 mg/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationNOREPINEPHRINE BITARTRATE 16 mg/250mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Norepinephrine Bitartrate — NDC 00338-0116-20," retrieved September 3, 2026, https://drugdashboards.com/drug/00338011620.

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