🇺🇸
United States · US · US:55292-122_5b563933-e1a3-418c-a1fd-0433d1d9233f
NEOPROFEN
Orange BookUNIISPLATC C01EB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRecordati Rare Diseases Inc.
CountryUS (United States)
ATC codeC01EB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155292122523 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
N01ORX9D6S
IBUPROFEN LYSINE
RxCUI 36761
Orange Book
N021903
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "N01ORX9D6S",
"rxcui": "36761",
"inchikey": "IHHXIUAEPKVVII-ZSCHJXSPSA-N",
"display_name": "IBUPROFEN LYSINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"6f5ede6f-b0b7-4fc8-969e-652f60ead047": {
"match": "brand_token",
"title": "NEOPROFEN (IBUPROFEN LYSINE) SOLUTION [RECORDATI RARE DISEASES INC.]",
"spl_version": "17",
"published_date": "2024-10-17"
}
},
"productid": "55292-122_5b563933-e1a3-418c-a1fd-0433d1d9233f",
"productndc": "55292-122",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "021903",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 20MG BASE/2ML (EQ 10MG BASE/ML)",
"product_no": "001",
"approval_date": "Apr 13, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN LYSINE",
"proprietary_name": "NEOPROFEN",
"active_ingred_unit": "mg/mL",
"application_number": "NDA021903",
"marketing_category": "NDA",
"nonproprietary_name": "ibuprofen lysine",
"start_marketing_date": "20060413",
"active_numerator_strength": "10"
}Related drugs
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