ropivacaine hydrochloride

Generic: ropivacaine hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ropivacaine hydrochloride
Generic Name ropivacaine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
EPIDURAL INFILTRATION PERINEURAL
Active Ingredients

ropivacaine hydrochloride 2 mg/mL

Manufacturer
FRESENIUS KABI USA, LLC

Identifiers & Regulatory

Product NDC 65219-632
Product ID 65219-632_7203f32f-2e48-4924-b882-d4f3863ae952
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212808
Listing Expiration 2026-12-31
Marketing Start 2024-12-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219632
Hyphenated Format 65219-632

Supplemental Identifiers

RxCUI
1734347 1734355
UPC
0365219632047 0365219632023
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 PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 24 BAG in 1 CASE (65219-632-10) / 100 mL in 1 BAG (65219-632-02)
  • 24 BAG in 1 CASE (65219-632-20) / 200 mL in 1 BAG (65219-632-04)
source: ndc

Packages (2)

65219-632-10 24 BAG in 1 CASE (65219-632-10) / 100 mL in 1 BAG (65219-632-02) 65219-632-20 24 BAG in 1 CASE (65219-632-20) / 200 mL in 1 BAG (65219-632-04)

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": "7203f32f-2e48-4924-b882-d4f3863ae952", "openfda": {"upc": ["0365219632047", "0365219632023"], "unii": ["V910P86109"], "rxcui": ["1734347", "1734355"], "spl_set_id": ["da4a7675-97bf-4d2a-9fdc-c1b4b2999126"], "manufacturer_name": ["FRESENIUS KABI USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 BAG in 1 CASE (65219-632-10)  / 100 mL in 1 BAG (65219-632-02)", "package_ndc": "65219-632-10", "marketing_start_date": "20250203"}, {"sample": false, "description": "24 BAG in 1 CASE (65219-632-20)  / 200 mL in 1 BAG (65219-632-04)", "package_ndc": "65219-632-20", "marketing_start_date": "20250203"}], "brand_name": "Ropivacaine Hydrochloride", "product_id": "65219-632_7203f32f-2e48-4924-b882-d4f3863ae952", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "65219-632", "generic_name": "Ropivacaine Hydrochloride", "labeler_name": "FRESENIUS KABI USA, LLC", "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": "20241210", "listing_expiration_date": "20261231"}