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Active ingredient

Ropivacaine

79 finished FDA listings contain Ropivacaine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ROPIVACAINE, ROPIVACAINE HYDROCHLORIDE
Dosage forms
Injection, Injection, Solution
Routes
Epidural, Infiltration, Perineural
Manufacturers / labelers
20
Strengths listed
10 mg/ml · 150 mg/30ml · 2 mg/ml · 5 mg/ml · 7.5 mg/ml
Brand names in FDA listings
Naropin

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 35780

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020533FRESENIUS KABI USA1996-09-2412
ANDA 205612EUGIA PHARMA2016-07-138
ANDA 206166INFORLIFE2018-06-113
ANDA 207636SOMERSET THERAPS LLC2018-06-159
ANDA 212808CAPLIN2020-04-0915
ANDA 214074HIKMA2020-07-204
ANDA 210102GLAND2022-08-184
ANDA 216605AMNEAL2023-03-084
ANDA 206091MYLAN LABS LTD2023-10-262
ANDA 218713KINDOS2024-07-307
ANDA 211907HIKMA2024-08-153
ANDA 219883ADAPTIS2025-03-218

Official labeling on DailyMed

Showing the 12 most recent of 28 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.