neoprofen

Generic: ibuprofen lysine

Labeler: recordati rare diseases inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name neoprofen
Generic Name ibuprofen lysine
Labeler recordati rare diseases inc.
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

ibuprofen lysine 10 mg/mL

Manufacturer
Recordati Rare Diseases Inc.

Identifiers & Regulatory

Product NDC 55292-122
Product ID 55292-122_5b563933-e1a3-418c-a1fd-0433d1d9233f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021903
Listing Expiration 2026-12-31
Marketing Start 2006-04-13

Pharmacologic Class

Classes
anti-inflammatory agents non-steroidal [cs] cyclooxygenase inhibitors [moa] nonsteroidal anti-inflammatory drug [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55292122
Hyphenated Format 55292-122

Supplemental Identifiers

RxCUI
637197 1747294
UNII
N01ORX9D6S

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 neoprofen (source: ndc)
Generic Name ibuprofen lysine (source: ndc)
Application Number NDA021903 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL
source: ndc

Packages (1)

55292-122-52 3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL

Ingredients (1)

ibuprofen lysine (10 mg/mL)

Linked Drug Pages (1)

NEOPROFEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5b563933-e1a3-418c-a1fd-0433d1d9233f", "openfda": {"unii": ["N01ORX9D6S"], "rxcui": ["637197", "1747294"], "spl_set_id": ["6f5ede6f-b0b7-4fc8-969e-652f60ead047"], "manufacturer_name": ["Recordati Rare Diseases Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 VIAL in 1 CARTON (55292-122-52)  / 2 mL in 1 VIAL", "package_ndc": "55292-122-52", "marketing_start_date": "20060413"}], "brand_name": "NEOPROFEN", "product_id": "55292-122_5b563933-e1a3-418c-a1fd-0433d1d9233f", "dosage_form": "SOLUTION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "55292-122", "generic_name": "ibuprofen lysine", "labeler_name": "Recordati Rare Diseases Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NEOPROFEN", "active_ingredients": [{"name": "IBUPROFEN LYSINE", "strength": "10 mg/mL"}], "application_number": "NDA021903", "marketing_category": "NDA", "marketing_start_date": "20060413", "listing_expiration_date": "20261231"}