DrugDashboards

Rocuronium Bromide

rocuronium bromide · ROCURONIUM BROMIDE 100 mg/10mL · Injection · Intravenous · Solco Healthcare US, LLC

NDC 43547-0531-10 · 10 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE · ANDA · View full market →

The short version

13 companies supply this market — deep enough that no single failure threatens the supply. It is in shortage right now. One of its named manufacturing plants, Zhejiang Huahai Pharmaceutical Co., 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.

Estimated fill cost

WAC per package, as filed
$71.61
Reported to Texas DSHS · 2026 annual filing · Solco Healthcare

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

Supply fragility

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

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for rocuronium bromide (injectable) in the next 90 days

sterile injectable · OAI inspection at a producing facility (24 months) · sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is 3× 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
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA212668
TE code
AP
Approval date
May 26, 2022
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0143-9250-10)Feb 15, 2023
    month 43 — 2× the typical 20-month injectable shortage · model puts 31% odds it resolves within 6 months
  • In shortage now — Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0143-9251-10)Feb 15, 2023
    month 43 — 2× the typical 20-month injectable shortage · model puts 31% odds it resolves within 6 months
  • In shortage now — Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 25021-687-05)Feb 15, 2023
    month 43 — 2× the typical 20-month injectable shortage · model puts 31% odds it resolves within 6 months
  • In shortage now — Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 67457-228-05)Feb 15, 2023
    month 43 — 2× the typical 20-month injectable shortage · model puts 31% odds it resolves within 6 months
  • In shortage now — Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 67457-228-10)Feb 15, 2023
    month 43 — 2× the typical 20-month injectable shortage · model puts 31% odds it resolves within 6 months
  • In shortage now — Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 71288-700-06)Feb 15, 2023
    month 43 — 2× the typical 20-month injectable shortage · model puts 31% odds it resolves within 6 months
  • In shortage now — Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 71288-718-11)Feb 15, 2023
    month 43 — 2× the typical 20-month injectable shortage · model puts 31% odds it resolves within 6 months
  • In shortage now — Rocuronium Bromide, Injection, 100 mg/10 mL (NDC 43066-013-10)Feb 15, 2023
    month 43 — 2× the typical 20-month injectable shortage · model puts 31% odds it resolves within 6 months
  • In shortage now — Rocuronium Bromide, Injection, 50 mg/5 mL (NDC 43066-007-10)Feb 15, 2023
    month 43 — 2× the typical 20-month injectable shortage · model puts 31% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of rocuronium bromide (Injection)

LabelerStrengthFirst seenLast seen
Civica, Inc.ROCURONIUM BROMIDE 10 mg/mLJul 15, 2026Sep 3, 2026
Gland Pharma LimitedROCURONIUM BROMIDE 10 mg/mLJul 15, 2026Sep 3, 2026
HF Acquisition Co. LLC, DBA HealthFirstROCURONIUM BROMIDE 10 mg/mLAug 14, 2026Sep 3, 2026
Meitheal Pharmaceuticals Inc.ROCURONIUM BROMIDE 10 mg/mLJul 15, 2026Sep 3, 2026
B. Braun Medical Inc.ROCURONIUM BROMIDE 50 mg/5mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationROCURONIUM BROMIDE 50 mg/5mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationROCURONIUM BROMIDE 100 mg/10mLJul 15, 2026Sep 2, 2026
Lifestar Pharma LLCROCURONIUM BROMIDE 50 mg/5mLJul 15, 2026Sep 2, 2026
Lifestar Pharma LLCROCURONIUM BROMIDE 100 mg/10mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLCROCURONIUM BROMIDE 50 mg/5mLJul 15, 2026Sep 2, 2026
Medical Purchasing Solutions, LLCROCURONIUM BROMIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Mylan Institutional LLCROCURONIUM BROMIDE 10 mg/mLJul 15, 2026Sep 2, 2026
ProPharma DistributionROCURONIUM BROMIDE 10 mg/mLJul 29, 2026Sep 2, 2026
Sagent PharmaceuticalsROCURONIUM BROMIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Solco Healthcare US, LLCROCURONIUM BROMIDE 50 mg/5mLJul 15, 2026Sep 2, 2026
Solco Healthcare US, LLCROCURONIUM BROMIDE 100 mg/10mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ROCURONIUM BROMIDE 10 mg/mLJul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Rocuronium Bromide — NDC 43547-0531-10," retrieved September 3, 2026, https://drugdashboards.com/drug/43547053110.

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