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United States · US · US:68788-8710_5a43a8c9-5f4d-4795-a10a-835cbe206613
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 · 9
- ndc116878887101100 TABLET, FILM COATED in 1 BOTTLE (68788-8710-1)
- ndc11687888710220 TABLET, FILM COATED in 1 BOTTLE (68788-8710-2)
- ndc11687888710330 TABLET, FILM COATED in 1 BOTTLE (68788-8710-3)
- ndc11687888710414 TABLET, FILM COATED in 1 BOTTLE (68788-8710-4)
- ndc11687888710550 TABLET, FILM COATED in 1 BOTTLE (68788-8710-5)
- ndc11687888710660 TABLET, FILM COATED in 1 BOTTLE (68788-8710-6)
- ndc11687888710721 TABLET, FILM COATED in 1 BOTTLE (68788-8710-7)
- ndc116878887108120 TABLET, FILM COATED in 1 BOTTLE (68788-8710-8)
- ndc11687888710990 TABLET, FILM COATED in 1 BOTTLE (68788-8710-9)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A078329
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": "68788-8710_5a43a8c9-5f4d-4795-a10a-835cbe206613",
"productndc": "68788-8710",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078329",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Feb 5, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "Feb 5, 2009"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "003",
"approval_date": "Feb 5, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078329",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20240705",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code G02CC01.
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