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Sodium Acetate

Sodium Acetate · SODIUM ACETATE ANHYDROUS 164 mg/mL · Injection, Solution, Concentrate · Intravenous · Amneal Pharmaceuticals Private Limited

NDC 80830-2435-02 · 25 BOTTLE, PLASTIC in 1 CARTON / 20 mL in 1 BOTTLE, PLASTIC · ANDA · View full market →

The short version

4 companies supply this market — a reasonable cushion if one runs into trouble. It is in shortage right now — FDA lists the reason as “other.

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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.

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 · avg $88.80 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA218469
TE code
AP
Approval date
Aug 8, 2025
Patents / exclusivity
None on file

Shortage history

  • In shortage now Sodium Acetate, Injection, 100 mEq/50mL (2 mEq/mL) (NDC 71357-007-10)Mar 23, 2016
    month 126 — 6× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now Sodium Acetate, Injection, 4 meq/100 mL (NDC 63323-032-00)Mar 23, 2016
    month 126 — 6× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now Sodium Acetate, Injection, 100 mEq/50 mL (2 mEq/mL) (NDC 0409-3299-05)Feb 3, 2016
    month 128 — 6× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now Sodium Acetate, Injection, 100 mEq/50 mL (2 mEq/mL) (NDC 0409-3299-26)Feb 3, 2016
    month 128 — 6× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now Sodium Acetate, Injection, 200 mEq/100 mL (2 mEq/mL) (NDC 0409-3299-06)Feb 3, 2016
    Other
    month 128 — 6× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now Sodium Acetate, Injection, 200 mEq/100 mL (2 mEq/mL) (NDC 0409-3299-25)Feb 3, 2016
    month 128 — 6× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now Sodium Acetate, Injection, 40 mEq/20 mL (2 mEq/mL) (NDC 0409-7299-25)Feb 3, 2016
    month 128 — 6× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now Sodium Acetate, Injection, 40 mEq/20 mL (2 mEq/mL) (NDC 0409-7299-73)Feb 3, 2016
    month 128 — 6× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now Sodium Acetate, Injection, 40 mEq/20mL (2 mEq/mL) (NDC 71357-002-10)Feb 3, 2016
    month 128 — 6× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Sodium Acetate (Injection, Solution, Concentrate)

LabelerStrengthFirst seenLast seen
Hospira, Inc.SODIUM ACETATE ANHYDROUS 164 mg/mLJul 15, 2026Sep 3, 2026
Milla Pharmaceuticals Inc.SODIUM ACETATE 164 mg/mLJul 15, 2026Sep 3, 2026
Fresenius Kabi USA, LLCSODIUM ACETATE 4 meq/100mLJul 15, 2026Sep 2, 2026
Hospira, Inc.SODIUM ACETATE ANHYDROUS 3.28 g/20mLJul 15, 2026Aug 31, 2026
Amneal Pharmaceuticals Private LimitedSODIUM ACETATE ANHYDROUS 164 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Sodium Acetate — NDC 80830-2435-02," retrieved September 3, 2026, https://drugdashboards.com/drug/80830243502.

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