ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

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

Drug Facts

Product Profile

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

ropivacaine hydrochloride 2 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9196
Product ID 0143-9196_c4abd4d6-435c-4d2a-b670-717af36ceada
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211907
Listing Expiration 2027-12-31
Marketing Start 2025-11-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439196
Hyphenated Format 0143-9196

Supplemental Identifiers

RxCUI
1734347 1734355 1734479
UPC
0301439195016 0301439196013 0301439197010
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 ANDA211907 (source: ndc)
Routes
EPIDURAL INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 12 BAG in 1 CASE (0143-9196-12) / 200 mL in 1 BAG (0143-9196-01)
source: ndc

Packages (1)

0143-9196-12 12 BAG in 1 CASE (0143-9196-12) / 200 mL in 1 BAG (0143-9196-01)

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": "c4abd4d6-435c-4d2a-b670-717af36ceada", "openfda": {"upc": ["0301439195016", "0301439196013", "0301439197010"], "unii": ["V910P86109"], "rxcui": ["1734347", "1734355", "1734479"], "spl_set_id": ["3d465e02-fd09-41b8-847f-bfe99cb4a712"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BAG in 1 CASE (0143-9196-12)  / 200 mL in 1 BAG (0143-9196-01)", "package_ndc": "0143-9196-12", "marketing_start_date": "20251107"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "0143-9196_c4abd4d6-435c-4d2a-b670-717af36ceada", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "0143-9196", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ropivacaine Hydrochloride", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "2 mg/mL"}], "application_number": "ANDA211907", "marketing_category": "ANDA", "marketing_start_date": "20251107", "listing_expiration_date": "20271231"}