ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: caplin steriles limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler caplin steriles limited
Dosage Form INJECTION
Routes
EPIDURAL INFILTRATION
Active Ingredients

ropivacaine hydrochloride 2 mg/mL

Manufacturer
Caplin Steriles Limited

Identifiers & Regulatory

Product NDC 65145-166
Product ID 65145-166_2d5d4dcd-b082-4bbb-838b-615d0f14bbc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212808
Listing Expiration 2026-12-31
Marketing Start 2025-06-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65145166
Hyphenated Format 65145-166

Supplemental Identifiers

RxCUI
1734084 1734207 1734347 1734355 1734475 1734483
UPC
0365145108104 0365145108012 0365145109101 0365145166012 0365145107015 0365145107107 0365145110015 0365145165015 0365145109019 0365145110107
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 ANDA212808 (source: ndc)
Routes
EPIDURAL INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 CASE (65145-166-10) / 1 BAG in 1 POUCH (65145-166-01) / 200 mL in 1 BAG
source: ndc

Packages (1)

65145-166-10 10 POUCH in 1 CASE (65145-166-10) / 1 BAG in 1 POUCH (65145-166-01) / 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": "2d5d4dcd-b082-4bbb-838b-615d0f14bbc5", "openfda": {"upc": ["0365145108104", "0365145108012", "0365145109101", "0365145166012", "0365145107015", "0365145107107", "0365145110015", "0365145165015", "0365145109019", "0365145110107"], "unii": ["V910P86109"], "rxcui": ["1734084", "1734207", "1734347", "1734355", "1734475", "1734483"], "spl_set_id": ["a9010ea8-0923-44e4-a7c7-7d65d37d06db"], "manufacturer_name": ["Caplin Steriles Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CASE (65145-166-10)  / 1 BAG in 1 POUCH (65145-166-01)  / 200 mL in 1 BAG", "package_ndc": "65145-166-10", "marketing_start_date": "20250624"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "65145-166_2d5d4dcd-b082-4bbb-838b-615d0f14bbc5", "dosage_form": "INJECTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "65145-166", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "Caplin Steriles Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropivacaine Hydrochloride", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA212808", "marketing_category": "ANDA", "marketing_start_date": "20250624", "listing_expiration_date": "20261231"}