naropin

Generic: ropivacaine hydrochloride

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

Drug Facts

Product Profile

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

ropivacaine hydrochloride 5 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-286
Product ID 63323-286_324532ac-4e54-4659-a1a2-9ade22a1ed3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020533
Listing Expiration 2026-12-31
Marketing Start 2009-08-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323286
Hyphenated Format 63323-286

Supplemental Identifiers

RxCUI
1734203 1734204 1734207 1734208 1734347 1734348 1734355 1734356 1734475 1734476 1734479 1734480 1734481 1734482 1734483 1734484
UPC
0363323286439 0363323285418 0363323286415 0363323285593 0363323285531
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 naropin (source: ndc)
Generic Name ropivacaine hydrochloride (source: ndc)
Application Number NDA020533 (source: ndc)
Routes
EPIDURAL INFILTRATION PERINEURAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-27) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-286-41)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-38) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-43)
source: ndc

Packages (2)

63323-286-27 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-27) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-286-41) 63323-286-38 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-38) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-43)

Ingredients (1)

ropivacaine hydrochloride (5 mg/mL)

Linked Drug Pages (3)

Naropin ndc-match (0.9) Naropin ndc-match (0.9) Naropin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["EPIDURAL", "INFILTRATION", "PERINEURAL"], "spl_id": "324532ac-4e54-4659-a1a2-9ade22a1ed3f", "openfda": {"upc": ["0363323286439", "0363323285418", "0363323286415", "0363323285593", "0363323285531"], "unii": ["V910P86109"], "rxcui": ["1734203", "1734204", "1734207", "1734208", "1734347", "1734348", "1734355", "1734356", "1734475", "1734476", "1734479", "1734480", "1734481", "1734482", "1734483", "1734484"], "spl_set_id": ["dff4a1e4-4b2a-4a64-b6d8-ea470dee88f7"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-27)  / 20 mL in 1 VIAL, SINGLE-DOSE (63323-286-41)", "package_ndc": "63323-286-27", "marketing_start_date": "20090804"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-38)  / 30 mL in 1 VIAL, SINGLE-DOSE (63323-286-43)", "package_ndc": "63323-286-38", "marketing_start_date": "20090804"}], "brand_name": "Naropin", "product_id": "63323-286_324532ac-4e54-4659-a1a2-9ade22a1ed3f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "63323-286", "generic_name": "ROPIVACAINE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Naropin", "active_ingredients": [{"name": "ROPIVACAINE HYDROCHLORIDE", "strength": "5 mg/mL"}], "application_number": "NDA020533", "marketing_category": "NDA", "marketing_start_date": "20090804", "listing_expiration_date": "20261231"}