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United States · US · US:53746-137_32dbe366-3f8b-4ace-9ce4-a9b695c58d30
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 · 6
- ndc115374613701100 TABLET in 1 BOTTLE (53746-137-01)
- ndc115374613705500 TABLET in 1 BOTTLE (53746-137-05)
- ndc11537461373030 TABLET in 1 BOTTLE (53746-137-30)
- ndc11537461375050 TABLET in 1 BOTTLE (53746-137-50)
- ndc11537461376060 TABLET in 1 BOTTLE (53746-137-60)
- ndc11537461379090 TABLET in 1 BOTTLE (53746-137-90)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A071935
AB
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": "53746-137_32dbe366-3f8b-4ace-9ce4-a9b695c58d30",
"productndc": "53746-137",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "071935",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "001",
"approval_date": "Oct 13, 1987"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA071935",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20090105",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code G02CC01.
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