DrugDashboards

Iron Sucrose

Iron Sucrose · IRON SUCROSE 20 mg/mL · Injection · Intravenous · International Medication Systems, Limited

NDC 76329-9200-01 · 10 VIAL, SINGLE-DOSE in 1 PACKAGE / 2.5 mL in 1 VIAL, SINGLE-DOSE · ANDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, International Medication Systems, Ltd., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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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.

Medicare Part B (ASP)

Payment limit per 1 MG
$0.227
HCPCS J1756 · Jul 1, 2026 quarter · typically ASP + 6%

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
ANDA208977
TE code
AB
Approval date
Aug 8, 2025
Patents / exclusivity
0 patents, 1 exclusivities
TypeNumber / codeExpires
exclusivityCGTFeb 8, 2026

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Iron Sucrose (Injection)

LabelerStrengthFirst seenLast seen
International Medication Systems, LimitedIRON SUCROSE 20 mg/mLJul 15, 2026Sep 3, 2026
Sandoz IncIRON SUCROSE 100 mg/5mLJul 15, 2026Sep 2, 2026
Sandoz IncIRON SUCROSE 200 mg/10mLJul 15, 2026Sep 2, 2026
Sandoz IncIRON SUCROSE 50 mg/2.5mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Iron Sucrose — NDC 76329-9200-01," retrieved September 3, 2026, https://drugdashboards.com/drug/76329920001.

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