ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler baxter healthcare corporation
Dosage Form INJECTION
Routes
EPIDURAL INFILTRATION PERINEURAL
Active Ingredients

ropivacaine hydrochloride 5 mg/mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 43066-019
Product ID 43066-019_a8d08579-825f-40d9-b1e3-e47b73765ae6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212808
Listing Expiration 2026-12-31
Marketing Start 2020-04-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43066019
Hyphenated Format 43066-019

Supplemental Identifiers

RxCUI
1734084 1734207 1734475 1734483
UPC
0343066023010 0343066019013 0343066027018 0343066015015
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 ANDA212808 (source: ndc)
Routes
EPIDURAL INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (43066-019-10) / 20 mL in 1 VIAL (43066-019-01)
source: ndc

Packages (1)

43066-019-10 10 VIAL in 1 CARTON (43066-019-10) / 20 mL in 1 VIAL (43066-019-01)

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": "a8d08579-825f-40d9-b1e3-e47b73765ae6", "openfda": {"upc": ["0343066023010", "0343066019013", "0343066027018", "0343066015015"], "unii": ["V910P86109"], "rxcui": ["1734084", "1734207", "1734475", "1734483"], "spl_set_id": ["781d4b7f-7556-4695-8d48-7772d7a0d8e9"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (43066-019-10)  / 20 mL in 1 VIAL (43066-019-01)", "package_ndc": "43066-019-10", "marketing_start_date": "20200409"}], "brand_name": "ROPIVACAINE HYDROCHLORIDE", "product_id": "43066-019_a8d08579-825f-40d9-b1e3-e47b73765ae6", "dosage_form": "INJECTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "43066-019", "generic_name": "ropivacaine hydrochloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPIVACAINE HYDROCHLORIDE", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA212808", "marketing_category": "ANDA", "marketing_start_date": "20200409", "listing_expiration_date": "20261231"}