ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: sportpharm, inc. dba sportpharm
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler sportpharm, inc. dba sportpharm
Dosage Form INJECTION
Routes
EPIDURAL INFILTRATION PERINEURAL
Active Ingredients

ropivacaine hydrochloride 5 mg/mL

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-097
Product ID 85766-097_40a1cddb-0492-1635-e063-6294a90a3c5c
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 85766097
Hyphenated Format 85766-097

Supplemental Identifiers

RxCUI
1734475
UNII
V910P86109

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
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (85766-097-30) / 30 mL in 1 VIAL
source: ndc

Packages (1)

85766-097-30 1 VIAL in 1 CARTON (85766-097-30) / 30 mL in 1 VIAL

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": "40a1cddb-0492-1635-e063-6294a90a3c5c", "openfda": {"unii": ["V910P86109"], "rxcui": ["1734475"], "spl_set_id": ["56b664ad-03e0-4bf3-8efa-40ce3e8d3498"], "manufacturer_name": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (85766-097-30)  / 30 mL in 1 VIAL", "package_ndc": "85766-097-30", "marketing_start_date": "20251008"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "85766-097_40a1cddb-0492-1635-e063-6294a90a3c5c", "dosage_form": "INJECTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "85766-097", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "Sportpharm, Inc. dba Sportpharm", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropivacaine Hydrochloride", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA207636", "marketing_category": "ANDA", "marketing_start_date": "20180615", "listing_expiration_date": "20261231"}