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United States · US · US:68788-8757_c300eff8-05c9-4eaf-9de8-16d02e44eb2a
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
- ndc116878887571100 TABLET, FILM COATED in 1 BOTTLE (68788-8757-1)
- ndc11687888757220 TABLET, FILM COATED in 1 BOTTLE (68788-8757-2)
- ndc11687888757330 TABLET, FILM COATED in 1 BOTTLE (68788-8757-3)
- ndc11687888757414 TABLET, FILM COATED in 1 BOTTLE (68788-8757-4)
- ndc11687888757550 TABLET, FILM COATED in 1 BOTTLE (68788-8757-5)
- ndc11687888757660 TABLET, FILM COATED in 1 BOTTLE (68788-8757-6)
- ndc11687888757721 TABLET, FILM COATED in 1 BOTTLE (68788-8757-7)
- ndc116878887578120 TABLET, FILM COATED in 1 BOTTLE (68788-8757-8)
- ndc11687888757990 TABLET, FILM COATED in 1 BOTTLE (68788-8757-9)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A202413
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": "68788-8757_c300eff8-05c9-4eaf-9de8-16d02e44eb2a",
"productndc": "68788-8757",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202413",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Nov 23, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "Nov 23, 2016"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "003",
"approval_date": "Nov 23, 2016"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "300MG",
"product_no": "004",
"approval_date": "Jul 5, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA202413",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20241017",
"active_numerator_strength": "800"
}Related drugs
Other records sharing ATC code G02CC01.
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