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United States · US · US:68788-8438_212b5f4e-a83c-42a3-8b0d-ff0ce269b4c8
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc116878884381100 TABLET in 1 BOTTLE (68788-8438-1)
- ndc11687888438220 TABLET in 1 BOTTLE (68788-8438-2)
- ndc11687888438330 TABLET in 1 BOTTLE (68788-8438-3)
- ndc11687888438550 TABLET in 1 BOTTLE (68788-8438-5)
- ndc11687888438660 TABLET in 1 BOTTLE (68788-8438-6)
- ndc11687888438828 TABLET in 1 BOTTLE (68788-8438-8)
- ndc11687888438990 TABLET in 1 BOTTLE (68788-8438-9)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A213794
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": "68788-8438_212b5f4e-a83c-42a3-8b0d-ff0ce269b4c8",
"productndc": "68788-8438",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "213794",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "May 8, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "May 8, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "003",
"approval_date": "May 8, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213794",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20230428",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code G02CC01.
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