ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler somerset therapeutics, llc
Dosage Form INJECTION
Routes
EPIDURAL INFILTRATION PERINEURAL
Active Ingredients

ropivacaine hydrochloride 2 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-062
Product ID 70069-062_79b226f0-c08a-4f84-bf2b-ae5c60e01d67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207636
Listing Expiration 2026-12-31
Marketing Start 2018-06-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069062
Hyphenated Format 70069-062

Supplemental Identifiers

RxCUI
905189 1734084 1734090 1734203 1734207 1734475 1734483
UPC
0370069062104 0370069062258 0370069064252 0370069061251 0370069064016 0370069063255 0370069067017 0370069066102 0370069067109 0370069063019 0370069061015 0370069065259 0370069062012 0370069064108 0370069066256 0370069067253 0370069061107 0370069066010 0370069065013
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 ANDA207636 (source: ndc)
Routes
EPIDURAL INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (70069-062-10) / 20 mL in 1 VIAL (70069-062-01)
  • 25 VIAL in 1 CARTON (70069-062-25) / 20 mL in 1 VIAL (70069-062-01)
source: ndc

Packages (2)

70069-062-10 10 VIAL in 1 CARTON (70069-062-10) / 20 mL in 1 VIAL (70069-062-01) 70069-062-25 25 VIAL in 1 CARTON (70069-062-25) / 20 mL in 1 VIAL (70069-062-01)

Ingredients (1)

ropivacaine hydrochloride (2 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": "79b226f0-c08a-4f84-bf2b-ae5c60e01d67", "openfda": {"upc": ["0370069062104", "0370069062258", "0370069064252", "0370069061251", "0370069064016", "0370069063255", "0370069067017", "0370069066102", "0370069067109", "0370069063019", "0370069061015", "0370069065259", "0370069062012", "0370069064108", "0370069066256", "0370069067253", "0370069061107", "0370069066010", "0370069065013"], "unii": ["V910P86109"], "rxcui": ["905189", "1734084", "1734090", "1734203", "1734207", "1734475", "1734483"], "spl_set_id": ["ffeadbbf-4ca6-4ed8-94c1-6e0adf7fbe64"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (70069-062-10)  / 20 mL in 1 VIAL (70069-062-01)", "package_ndc": "70069-062-10", "marketing_start_date": "20220302"}, {"sample": false, "description": "25 VIAL in 1 CARTON (70069-062-25)  / 20 mL in 1 VIAL (70069-062-01)", "package_ndc": "70069-062-25", "marketing_start_date": "20180615"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "70069-062_79b226f0-c08a-4f84-bf2b-ae5c60e01d67", "dosage_form": "INJECTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "70069-062", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropivacaine Hydrochloride", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA207636", "marketing_category": "ANDA", "marketing_start_date": "20180615", "listing_expiration_date": "20261231"}