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United States · US · US:63187-489_7db62aa5-dd71-4f62-b656-c4df75686f02
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc11631874892020 TABLET in 1 BOTTLE (63187-489-20)
- ndc11631874893030 TABLET in 1 BOTTLE (63187-489-30)
- ndc11631874894040 TABLET in 1 BOTTLE (63187-489-40)
- ndc11631874894545 TABLET in 1 BOTTLE (63187-489-45)
- ndc11631874896060 TABLET in 1 BOTTLE (63187-489-60)
- ndc116318748972120 TABLET in 1 BOTTLE (63187-489-72)
- ndc11631874899090 TABLET in 1 BOTTLE (63187-489-90)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A078558
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "WK2XYI10QM",
"rxcui": "5640",
"inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
"display_name": "IBUPROFEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"aeee629b-255c-40d8-8e95-779aec00f723": {
"match": "brand_token",
"title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
"spl_version": "1",
"published_date": "2026-06-02"
}
},
"productid": "63187-489_7db62aa5-dd71-4f62-b656-c4df75686f02",
"productndc": "63187-489",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078558",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Jun 18, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "Jun 18, 2007"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "003",
"approval_date": "Jun 18, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078558",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20091123",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code G02CC01.
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