ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: propharma distribution
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler propharma distribution
Dosage Form INJECTION
Routes
EPIDURAL INFILTRATION PERINEURAL
Active Ingredients

ropivacaine hydrochloride 5 mg/mL

Manufacturer
ProPharma Distribution

Identifiers & Regulatory

Product NDC 84549-164
Product ID 84549-164_463f04e3-2619-2343-e063-6394a90a6ae4
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 84549164
Hyphenated Format 84549-164

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
  • 30 mL in 1 VIAL (84549-164-25)
source: ndc

Packages (1)

84549-164-25 30 mL in 1 VIAL (84549-164-25)

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": "463f04e3-2619-2343-e063-6394a90a6ae4", "openfda": {"unii": ["V910P86109"], "rxcui": ["1734475"], "spl_set_id": ["3f793f80-57da-1599-e063-6394a90a1dab"], "manufacturer_name": ["ProPharma Distribution"]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 VIAL (84549-164-25)", "package_ndc": "84549-164-25", "marketing_start_date": "20251010"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "84549-164_463f04e3-2619-2343-e063-6394a90a6ae4", "dosage_form": "INJECTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "84549-164", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "ProPharma Distribution", "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"}