ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

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

Drug Facts

Product Profile

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

ropivacaine hydrochloride 10 mg/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-737
Product ID 71288-737_f5ce6fdb-2cd1-4ebf-a884-541b2976534f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218713
Listing Expiration 2026-12-31
Marketing Start 2024-07-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288737
Hyphenated Format 71288-737

Supplemental Identifiers

RxCUI
905189 1734084 1734090 1734203 1734207 1734475 1734483
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 ANDA218713 (source: ndc)
Routes
EPIDURAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-737-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-737-10)
source: ndc

Packages (1)

71288-737-11 25 VIAL, SINGLE-DOSE in 1 CARTON (71288-737-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-737-10)

Ingredients (1)

ropivacaine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Ropivacaine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL"], "spl_id": "f5ce6fdb-2cd1-4ebf-a884-541b2976534f", "openfda": {"unii": ["V910P86109"], "rxcui": ["905189", "1734084", "1734090", "1734203", "1734207", "1734475", "1734483"], "spl_set_id": ["d00bfdee-d3e9-4faf-b079-43ac1add51b3"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (71288-737-11)  / 10 mL in 1 VIAL, SINGLE-DOSE (71288-737-10)", "package_ndc": "71288-737-11", "marketing_start_date": "20240730"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "71288-737_f5ce6fdb-2cd1-4ebf-a884-541b2976534f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "71288-737", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropivacaine Hydrochloride", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA218713", "marketing_category": "ANDA", "marketing_start_date": "20240730", "listing_expiration_date": "20261231"}