ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION
Active Ingredients

ropivacaine hydrochloride 2 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-263
Product ID 68083-263_59ffca85-dbbf-49c1-8516-027b9de5f396
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210102
Listing Expiration 2026-12-31
Marketing Start 2022-08-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083263
Hyphenated Format 68083-263

Supplemental Identifiers

RxCUI
1734347 1734355
UPC
0368083262013 0368083263010
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 ANDA210102 (source: ndc)
Routes
EPIDURAL INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 1 BAG in 1 POUCH (68083-263-01) / 200 mL in 1 BAG
source: ndc

Packages (1)

68083-263-01 1 BAG in 1 POUCH (68083-263-01) / 200 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"], "spl_id": "59ffca85-dbbf-49c1-8516-027b9de5f396", "openfda": {"upc": ["0368083262013", "0368083263010"], "unii": ["V910P86109"], "rxcui": ["1734347", "1734355"], "spl_set_id": ["643c1729-096e-459c-80c1-78b78e698da6"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 POUCH (68083-263-01)  / 200 mL in 1 BAG", "package_ndc": "68083-263-01", "marketing_start_date": "20220818"}], "brand_name": "Ropivacaine hydrochloride", "product_id": "68083-263_59ffca85-dbbf-49c1-8516-027b9de5f396", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "68083-263", "generic_name": "Ropivacaine hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropivacaine hydrochloride", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA210102", "marketing_category": "ANDA", "marketing_start_date": "20220818", "listing_expiration_date": "20261231"}