Ropivacaine Hydrochloride

Product NDC
65145-166
11-digit product format
651450166
Labeler code
65145
Product ID
65145-166_2d5d4dcd-b082-4bbb-838b-615d0f14bbc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropivacaine Hydrochloride
Dosage form
INJECTION
Route
EPIDURAL; INFILTRATION
Labeler
Caplin Steriles Limited
Application
ANDA212808
Marketing category
ANDA
Marketing start
2025-06-24
Substance
ROPIVACAINE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
V910P86109ROPIVACAINE HYDROCHLORIDE132112-35-7ROPIVACAINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65145-166-106514501661010 POUCH in 1 CASE (65145-166-10) / 1 BAG in 1 POUCH (65145-166-01) / 200 mL in 1 BAG10 pouch2025-06-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Ropivacaine HydrochlorideCaplin Steriles Limited2025-06-24Human Prescription Drug Label8