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United States · US · US:68788-8319_f854b253-22ef-4147-8608-d6c4f5446eb1
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
- ndc116878883191100 TABLET in 1 BOTTLE (68788-8319-1)
- ndc11687888319220 TABLET in 1 BOTTLE (68788-8319-2)
- ndc11687888319330 TABLET in 1 BOTTLE (68788-8319-3)
- ndc11687888319414 TABLET in 1 BOTTLE (68788-8319-4)
- ndc11687888319550 TABLET in 1 BOTTLE (68788-8319-5)
- ndc11687888319660 TABLET in 1 BOTTLE (68788-8319-6)
- ndc11687888319721 TABLET in 1 BOTTLE (68788-8319-7)
- ndc116878883198120 TABLET in 1 BOTTLE (68788-8319-8)
- ndc11687888319990 TABLET in 1 BOTTLE (68788-8319-9)
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": "68788-8319_f854b253-22ef-4147-8608-d6c4f5446eb1",
"productndc": "68788-8319",
"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": "20221223",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code G02CC01.
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