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
Active Ingredients

ropivacaine hydrochloride 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-288
Product ID 63323-288_75465ceb-e894-487d-aa80-671fa0841fce
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 63323288
Hyphenated Format 63323-288

Supplemental Identifiers

RxCUI
1734084 1734086 1734090 1734091
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
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 5 AMPULE in 1 BOX (63323-288-27) / 20 mL in 1 AMPULE (63323-288-25)
source: ndc

Packages (1)

63323-288-27 5 AMPULE in 1 BOX (63323-288-27) / 20 mL in 1 AMPULE (63323-288-25)

Ingredients (1)

ropivacaine hydrochloride (10 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"], "spl_id": "75465ceb-e894-487d-aa80-671fa0841fce", "openfda": {"unii": ["V910P86109"], "rxcui": ["1734084", "1734086", "1734090", "1734091"], "spl_set_id": ["56dfabf7-f7a8-4601-b17a-cb16fb995b0f"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 AMPULE in 1 BOX (63323-288-27)  / 20 mL in 1 AMPULE (63323-288-25)", "package_ndc": "63323-288-27", "marketing_start_date": "20090804"}], "brand_name": "Naropin", "product_id": "63323-288_75465ceb-e894-487d-aa80-671fa0841fce", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Local Anesthesia [PE]"], "product_ndc": "63323-288", "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": "10 mg/mL"}], "application_number": "NDA020533", "marketing_category": "NDA", "marketing_start_date": "19960924", "listing_expiration_date": "20261231"}