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United States · US · US:65162-466_32c8853c-ed52-4791-9350-ab724724d342
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc11651624660330 TABLET in 1 BOTTLE (65162-466-03)
- ndc11651624660550 TABLET in 1 BOTTLE (65162-466-05)
- ndc11651624660660 TABLET in 1 BOTTLE (65162-466-06)
- ndc11651624660990 TABLET in 1 BOTTLE (65162-466-09)
- ndc116516246610100 TABLET in 1 BOTTLE (65162-466-10)
- ndc116516246650500 TABLET in 1 BOTTLE (65162-466-50)
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": "65162-466_32c8853c-ed52-4791-9350-ab724724d342",
"productndc": "65162-466",
"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": "800"
}Related drugs
Other records sharing ATC code G02CC01.
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