ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
EPIDURAL INFILTRATION
Active Ingredients

ropivacaine hydrochloride 5 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9264
Product ID 0143-9264_ca74bdef-8c1f-4919-a7e9-a7655953b3af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214074
Listing Expiration 2027-12-31
Marketing Start 2025-11-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439264
Hyphenated Format 0143-9264

Supplemental Identifiers

RxCUI
905189 1734084 1734207 1734475
UPC
0301439265108 0301439266105 0301439263104 0301439264101
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 ANDA214074 (source: ndc)
Routes
EPIDURAL INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9264-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0143-9264-01)
source: ndc

Packages (1)

0143-9264-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9264-10) / 30 mL in 1 VIAL, SINGLE-DOSE (0143-9264-01)

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"], "spl_id": "ca74bdef-8c1f-4919-a7e9-a7655953b3af", "openfda": {"upc": ["0301439265108", "0301439266105", "0301439263104", "0301439264101"], "unii": ["V910P86109"], "rxcui": ["905189", "1734084", "1734207", "1734475"], "spl_set_id": ["35743510-728d-407b-b501-cf019665cd35"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9264-10)  / 30 mL in 1 VIAL, SINGLE-DOSE (0143-9264-01)", "package_ndc": "0143-9264-10", "marketing_start_date": "20251118"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "0143-9264_ca74bdef-8c1f-4919-a7e9-a7655953b3af", "dosage_form": "INJECTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "0143-9264", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropivacaine Hydrochloride", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "ANDA214074", "marketing_category": "ANDA", "marketing_start_date": "20251118", "listing_expiration_date": "20271231"}