ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

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

Drug Facts

Product Profile

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

ropivacaine hydrochloride 2 mg/mL

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-793
Product ID 68462-793_e7462792-eccf-4a36-9b80-1412035a9463
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219883
Listing Expiration 2026-12-31
Marketing Start 2025-08-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462793
Hyphenated Format 68462-793

Supplemental Identifiers

RxCUI
1734084 1734203 1734207 1734475 1734483
UPC
0368462778746 0368462777350 0368462795200 0368462793206 0368462777107 0368462793558 0368462794302 0368462778203
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 ANDA219883 (source: ndc)
Routes
EPIDURAL INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (68462-793-55) / 20 mL in 1 VIAL (68462-793-20)
  • 10 VIAL in 1 CARTON (68462-793-74) / 20 mL in 1 VIAL (68462-793-20)
source: ndc

Packages (2)

68462-793-55 25 VIAL in 1 CARTON (68462-793-55) / 20 mL in 1 VIAL (68462-793-20) 68462-793-74 10 VIAL in 1 CARTON (68462-793-74) / 20 mL in 1 VIAL (68462-793-20)

Ingredients (1)

ropivacaine hydrochloride (2 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": "e7462792-eccf-4a36-9b80-1412035a9463", "openfda": {"upc": ["0368462778746", "0368462777350", "0368462795200", "0368462793206", "0368462777107", "0368462793558", "0368462794302", "0368462778203"], "unii": ["V910P86109"], "rxcui": ["1734084", "1734203", "1734207", "1734475", "1734483"], "spl_set_id": ["043b28cc-ce5c-4351-a646-704c381decb9"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (68462-793-55)  / 20 mL in 1 VIAL (68462-793-20)", "package_ndc": "68462-793-55", "marketing_start_date": "20250807"}, {"sample": false, "description": "10 VIAL in 1 CARTON (68462-793-74)  / 20 mL in 1 VIAL (68462-793-20)", "package_ndc": "68462-793-74", "marketing_start_date": "20250807"}], "brand_name": "ROPIVACAINE HYDROCHLORIDE", "product_id": "68462-793_e7462792-eccf-4a36-9b80-1412035a9463", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "68462-793", "generic_name": "ROPIVACAINE HYDROCHLORIDE", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPIVACAINE HYDROCHLORIDE", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA219883", "marketing_category": "ANDA", "marketing_start_date": "20250807", "listing_expiration_date": "20261231"}