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United States · US · US:53746-464_769cfd1d-35d7-4f1a-ad8b-1bf642e02075
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc115374646401100 TABLET in 1 BOTTLE (53746-464-01)
- ndc115374646405500 TABLET in 1 BOTTLE (53746-464-05)
- ndc11537464643030 TABLET in 1 BOTTLE (53746-464-30)
- ndc11537464646060 TABLET in 1 BOTTLE (53746-464-60)
- ndc11537464649090 TABLET in 1 BOTTLE (53746-464-90)
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": "53746-464_769cfd1d-35d7-4f1a-ad8b-1bf642e02075",
"productndc": "53746-464",
"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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