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
Active Ingredients

ropivacaine hydrochloride 2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-285
Product ID 63323-285_cdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020533
Listing Expiration 2026-12-31
Marketing Start 1996-09-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323285
Hyphenated Format 63323-285

Supplemental Identifiers

RxCUI
905189 905191 1734084 1734086 1734090 1734091 1734203 1734204 1734207 1734208 1734347 1734348 1734355 1734356 1734475 1734476 1734479 1734480 1734481 1734482 1734483 1734484
UPC
0363323286033 0363323285074 0363323285036 0363323285579 0363323287030 0363323286095 0363323288075 0363323286330 0363323286057 0363323288037 0363323286118 0363323285517
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
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 5 AMPULE in 1 BOX (63323-285-10) / 10 mL in 1 AMPULE (63323-285-01)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-285-13) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-285-03)
  • 5 AMPULE in 1 BOX (63323-285-20) / 20 mL in 1 AMPULE (63323-285-06)
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-285-23) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-285-07)
  • 24 BAG in 1 CASE (63323-285-61) / 100 mL in 1 BAG (63323-285-02)
  • 24 BAG in 1 CASE (63323-285-63) / 200 mL in 1 BAG (63323-285-04)
  • 12 BOTTLE in 1 CASE (63323-285-64) / 200 mL in 1 BOTTLE (63323-285-57)
  • 12 BOTTLE in 1 CASE (63323-285-65) / 100 mL in 1 BOTTLE (63323-285-51)
source: ndc

Packages (8)

63323-285-10 5 AMPULE in 1 BOX (63323-285-10) / 10 mL in 1 AMPULE (63323-285-01) 63323-285-13 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-285-13) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-285-03) 63323-285-20 5 AMPULE in 1 BOX (63323-285-20) / 20 mL in 1 AMPULE (63323-285-06) 63323-285-23 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-285-23) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-285-07) 63323-285-61 24 BAG in 1 CASE (63323-285-61) / 100 mL in 1 BAG (63323-285-02) 63323-285-63 24 BAG in 1 CASE (63323-285-63) / 200 mL in 1 BAG (63323-285-04) 63323-285-64 12 BOTTLE in 1 CASE (63323-285-64) / 200 mL in 1 BOTTLE (63323-285-57) 63323-285-65 12 BOTTLE in 1 CASE (63323-285-65) / 100 mL in 1 BOTTLE (63323-285-51)

Ingredients (1)

ropivacaine hydrochloride (2 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"], "spl_id": "cdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9", "openfda": {"upc": ["0363323286033", "0363323285074", "0363323285036", "0363323285579", "0363323287030", "0363323286095", "0363323288075", "0363323286330", "0363323286057", "0363323288037", "0363323286118", "0363323285517"], "unii": ["V910P86109"], "rxcui": ["905189", "905191", "1734084", "1734086", "1734090", "1734091", "1734203", "1734204", "1734207", "1734208", "1734347", "1734348", "1734355", "1734356", "1734475", "1734476", "1734479", "1734480", "1734481", "1734482", "1734483", "1734484"], "spl_set_id": ["23d2d448-a744-4877-9f2d-7e57c198da89"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 AMPULE in 1 BOX (63323-285-10)  / 10 mL in 1 AMPULE (63323-285-01)", "package_ndc": "63323-285-10", "marketing_start_date": "20110531"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-285-13)  / 10 mL in 1 VIAL, SINGLE-DOSE (63323-285-03)", "package_ndc": "63323-285-13", "marketing_start_date": "20110531"}, {"sample": false, "description": "5 AMPULE in 1 BOX (63323-285-20)  / 20 mL in 1 AMPULE (63323-285-06)", "package_ndc": "63323-285-20", "marketing_start_date": "20110531"}, {"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (63323-285-23)  / 20 mL in 1 VIAL, SINGLE-DOSE (63323-285-07)", "package_ndc": "63323-285-23", "marketing_start_date": "20110531"}, {"sample": false, "description": "24 BAG in 1 CASE (63323-285-61)  / 100 mL in 1 BAG (63323-285-02)", "package_ndc": "63323-285-61", "marketing_start_date": "20110531"}, {"sample": false, "description": "24 BAG in 1 CASE (63323-285-63)  / 200 mL in 1 BAG (63323-285-04)", "package_ndc": "63323-285-63", "marketing_start_date": "20110531"}, {"sample": false, "description": "12 BOTTLE in 1 CASE (63323-285-64)  / 200 mL in 1 BOTTLE (63323-285-57)", "package_ndc": "63323-285-64", "marketing_start_date": "20110531"}, {"sample": false, "description": "12 BOTTLE in 1 CASE (63323-285-65)  / 100 mL in 1 BOTTLE (63323-285-51)", "package_ndc": "63323-285-65", "marketing_start_date": "20110531"}], "brand_name": "Naropin", "product_id": "63323-285_cdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "63323-285", "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": "2 mg/mL"}], "application_number": "NDA020533", "marketing_category": "NDA", "marketing_start_date": "19960924", "listing_expiration_date": "20261231"}