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, SOLUTION
Routes
EPIDURAL INFILTRATION PERINEURAL
Active Ingredients

ropivacaine hydrochloride 5 mg/mL

Manufacturer
Sportpharm, Inc. dba Sportpharm

Identifiers & Regulatory

Product NDC 85766-098
Product ID 85766-098_4340f7f5-c660-bd1a-e063-6394a90a4f1f
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 85766098
Hyphenated Format 85766-098

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 ANDA205612 (source: ndc)
Routes
EPIDURAL INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-01) / 30 mL in 1 VIAL, SINGLE-DOSE
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-25) / 30 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

85766-098-01 1 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-01) / 30 mL in 1 VIAL, SINGLE-DOSE 85766-098-25 25 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-25) / 30 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": "4340f7f5-c660-bd1a-e063-6394a90a4f1f", "openfda": {"unii": ["V910P86109"], "rxcui": ["1734475"], "spl_set_id": ["7327766c-19f0-4d83-89c6-eb685e0d286c"], "manufacturer_name": ["Sportpharm, Inc. dba Sportpharm"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-01)  / 30 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "85766-098-01", "marketing_start_date": "20251015"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (85766-098-25)  / 30 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "85766-098-25", "marketing_start_date": "20251015"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "85766-098_4340f7f5-c660-bd1a-e063-6394a90a4f1f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "85766-098", "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": "ANDA205612", "marketing_category": "ANDA", "marketing_start_date": "20160915", "listing_expiration_date": "20261231"}