ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION PERINEURAL
Active Ingredients

ropivacaine hydrochloride 2 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-798
Product ID 67457-798_78b68980-9e8d-4f38-ba2a-a9d520451f5d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206091
Listing Expiration 2026-12-31
Marketing Start 2024-03-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457798
Hyphenated Format 67457-798

Supplemental Identifiers

RxCUI
1734347 1734355
UPC
0367457798103 0367457799209
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 ANDA206091 (source: ndc)
Routes
EPIDURAL INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (67457-798-99) / 1 BAG in 1 POUCH (67457-798-10) / 100 mL in 1 BAG
source: ndc

Packages (1)

67457-798-99 10 POUCH in 1 CARTON (67457-798-99) / 1 BAG in 1 POUCH (67457-798-10) / 100 mL in 1 BAG

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", "PERINEURAL"], "spl_id": "78b68980-9e8d-4f38-ba2a-a9d520451f5d", "openfda": {"upc": ["0367457798103", "0367457799209"], "unii": ["V910P86109"], "rxcui": ["1734347", "1734355"], "spl_set_id": ["9e1d1b15-c224-4ff4-a39d-3b9cebfc8403"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (67457-798-99)  / 1 BAG in 1 POUCH (67457-798-10)  / 100 mL in 1 BAG", "package_ndc": "67457-798-99", "marketing_start_date": "20240318"}], "brand_name": "ROPIVACAINE HYDROCHLORIDE", "product_id": "67457-798_78b68980-9e8d-4f38-ba2a-a9d520451f5d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "67457-798", "generic_name": "ROPIVACAINE HYDROCHLORIDE", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROPIVACAINE HYDROCHLORIDE", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA206091", "marketing_category": "ANDA", "marketing_start_date": "20240318", "listing_expiration_date": "20261231"}