DrugDashboards

Sodium Chloride

sodium chloride · SODIUM CHLORIDE 450 mg/100mL · Injection · Intravenous · Baxter Healthcare Corporation

NDC 00338-0160-01 · 30 BAG in 1 CARTON / 50 mL in 1 BAG · NDA · View full market →

The short version

11 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Baxter Healthcare Corporation, failed FDA inspectionwithin the last two years — the agency’s most serious outcome. Historically, drugs in this position went on to a new shortage within 90 days about 1.5% of the time — roughly 10× the typical drug (0.1%).

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.

Supply fragility

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

90-day shortage risk (model v2)

1.5%chance of a new FDA shortage posting for sodium chloride (injectable) in the next 90 days

sterile injectable · 13 Class I/II recall(s) in 12 months · OAI inspection at a producing facility (24 months)

For scale: the typical drug’s chance is about 0.1% — this one is 10× that.

Backtested statistical model over the whole market, not this package alone. Model details →

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 · avg $16.68 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA020178
TE code
AP
Approval date
Dec 7, 1992
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 sodium chloride (Injection)

LabelerStrengthFirst seenLast seen
Baxter Healthcare CorporationSODIUM CHLORIDE 450 mg/100mLJul 15, 2026Sep 3, 2026
Baxter Healthcare CorporationSODIUM CHLORIDE 450 mg/50mLJul 15, 2026Sep 3, 2026
Baxter Healthcare CorporationSODIUM CHLORIDE 900 mg/100mLJul 15, 2026Sep 3, 2026
B. Braun Medical Inc.SODIUM CHLORIDE 9 mg/mLJul 15, 2026Sep 2, 2026
Cardinal Health 107, LLCSODIUM CHLORIDE 9 mg/mLJul 15, 2026Sep 2, 2026
Fresenius Medical Care de Mexico, S.A. de C.V.SODIUM CHLORIDE 900 mg/100mLJul 15, 2026Sep 2, 2026
Fresenius Medical Care Renal Therapies Group, LLCSODIUM CHLORIDE 900 mg/100mLJul 15, 2026Sep 2, 2026
Henry Schein, Inc.SODIUM CHLORIDE 9 mg/mLJul 15, 2026Sep 2, 2026
Liebel-Flarsheim Company LLCSODIUM CHLORIDE .9 mg/mLJul 15, 2026Sep 2, 2026
Nephron Pharmaceuticals CorporationSODIUM CHLORIDE 9 mg/mLJul 15, 2026Sep 2, 2026
Sanofi Vaccines US Inc.SODIUM CHLORIDE 4.5 mg/.5mLJul 15, 2026Sep 2, 2026
Fresenius Kabi USA, LLCSODIUM CHLORIDE 9 mg/mLJul 15, 2026Aug 31, 2026
Hikma Pharmaceuticals USA Inc.SODIUM CHLORIDE 9 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Sodium Chloride — NDC 00338-0160-01," retrieved September 3, 2026, https://drugdashboards.com/drug/00338016001.

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