DrugDashboards

Ropivacaine Hydrochloride

Ropivacaine Hydrochloride · ROPIVACAINE HYDROCHLORIDE 7.5 mg/mL · Injection · Epidural; Perineural · Somerset Therapeutics, LLC

NDC 70069-0065-25 · 25 VIAL in 1 CARTON / 20 mL in 1 VIAL · ANDA · View full market →

The short version

10 companies supply this market — deep enough that no single failure threatens the supply. It is in shortage right now — FDA lists the reason as “other”. One of its named manufacturing plants, Somerset Therapeutics Private Limited, failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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.

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
ANDA207636
TE code
AP
Approval date
Jun 15, 2018
Patents / exclusivity
None on file

Shortage history

  • In shortage now — Ropivacaine Hydrochloride, Injection, 10 mg/1 mL (NDC 43066-027-10)Dec 22, 2020
    month 69 — 3× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 2 mg/1 mL (NDC 43066-015-10)Dec 22, 2020
    Other
    month 69 — 3× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 5 mg/1 mL (NDC 43066-019-10)Dec 22, 2020
    month 69 — 3× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 5 mg/1 mL (NDC 43066-023-10)Dec 22, 2020
    Other
    month 69 — 3× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 10 mg/1 mL (NDC 70069-067-10)Mar 23, 2018
    month 102 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 10 mg/1 mL (NDC 70069-067-25)Mar 23, 2018
    month 102 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 2 mg/1 mL (NDC 70069-061-10)Mar 23, 2018
    month 102 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 2 mg/1 mL (NDC 70069-061-25)Mar 23, 2018
    month 102 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 2 mg/1 mL (NDC 70069-062-10)Mar 23, 2018
    month 102 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 2 mg/1 mL (NDC 70069-062-25)Mar 23, 2018
    month 102 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 5 mg/1 mL (NDC 70069-063-25)Mar 23, 2018
    month 102 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 5 mg/1 mL (NDC 70069-064-01)Mar 23, 2018
    month 102 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 5 mg/1 mL (NDC 70069-064-10)Mar 23, 2018
    month 102 — 5× the typical 20-month injectable shortage · model puts 24% odds it resolves within 6 months
  • In shortage now — Ropivacaine Hydrochloride, Injection, 5 mg/1 mL (NDC 70069-064-25)Mar 23, 2018
    month 102 — 5× 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 Ropivacaine Hydrochloride (Injection)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals LLCROPIVACAINE HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 3, 2026
Caplin Steriles LimitedROPIVACAINE HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 3, 2026
Somerset Therapeutics, LLCROPIVACAINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 3, 2026
Somerset Therapeutics, LLCROPIVACAINE HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 3, 2026
Somerset Therapeutics, LLCROPIVACAINE HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 3, 2026
Armas Pharmaceuticals Inc.ROPIVACAINE HYDROCHLORIDE 150 mg/30mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationROPIVACAINE HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationROPIVACAINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Caplin Steriles LimitedROPIVACAINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Civica, Inc.ROPIVACAINE HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ROPIVACAINE HYDROCHLORIDE 2 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ROPIVACAINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ROPIVACAINE HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Hikma Pharmaceuticals USA Inc.ROPIVACAINE HYDROCHLORIDE 7.5 mg/mLJul 15, 2026Sep 2, 2026
ProPharma DistributionROPIVACAINE HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Somerset Therapeutics, LLCROPIVACAINE HYDROCHLORIDE 7.5 mg/mLJul 15, 2026Sep 2, 2026
Sportpharm LLCROPIVACAINE HYDROCHLORIDE 5 mg/mLJul 15, 2026Sep 2, 2026
Baxter Healthcare CorporationROPIVACAINE HYDROCHLORIDE 5 mg/mLJul 15, 2026Aug 31, 2026
Caplin Steriles LimitedROPIVACAINE HYDROCHLORIDE 2 mg/mLJul 15, 2026Aug 31, 2026
Amneal Pharmaceuticals LLCROPIVACAINE HYDROCHLORIDE 5 mg/mLJul 15, 2026Aug 28, 2026
NorthStar Rx LLCROPIVACAINE HYDROCHLORIDE 5 mg/mLJul 15, 2026Aug 6, 2026
NorthStar Rx LLCROPIVACAINE HYDROCHLORIDE 10 mg/mLJul 15, 2026Aug 5, 2026
NorthStar Rx LLCROPIVACAINE HYDROCHLORIDE 2 mg/mLJul 15, 2026Aug 5, 2026

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

Cite this page

DrugDashboards, "Ropivacaine Hydrochloride — NDC 70069-0065-25," retrieved September 3, 2026, https://drugdashboards.com/drug/70069006525.

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