ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION PERINEURAL
Active Ingredients

ropivacaine hydrochloride 5 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-197
Product ID 55150-197_34725b26-d6e9-4d1b-95a0-da03764cc102
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205612
Listing Expiration 2026-12-31
Marketing Start 2016-09-15

Pharmacologic Class

Classes
amide local anesthetic [epc] amides [cs] local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150197
Hyphenated Format 55150-197

Supplemental Identifiers

RxCUI
905189 1734084 1734090 1734207 1734347 1734475 1734483
UPC
0355150195206 0355150199204 0355150198306 0355150196999 0355150200108 0355150197200 0355150201204
UNII
V910P86109

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ropivacaine hydrochloride (source: ndc)
Generic Name ropivacaine hydrochloride (source: ndc)
Application Number ANDA205612 (source: ndc)
Routes
EPIDURAL INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-197-20) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-197-20 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-197-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ropivacaine hydrochloride (5 mg/mL)

Linked Drug Pages (1)

Ropivacaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INFILTRATION", "PERINEURAL"], "spl_id": "34725b26-d6e9-4d1b-95a0-da03764cc102", "openfda": {"upc": ["0355150195206", "0355150199204", "0355150198306", "0355150196999", "0355150200108", "0355150197200", "0355150201204"], "unii": ["V910P86109"], "rxcui": ["905189", "1734084", "1734090", "1734207", "1734347", "1734475", "1734483"], "spl_set_id": ["3763b7b6-da49-4658-b93d-28f5da24d09e"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-197-20)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-197-20", "marketing_start_date": "20160915"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "55150-197_34725b26-d6e9-4d1b-95a0-da03764cc102", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "55150-197", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropivacaine Hydrochloride", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA205612", "marketing_category": "ANDA", "marketing_start_date": "20160915", "listing_expiration_date": "20261231"}