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United States · US · US:54348-835_eaa5cc60-19cc-a3f1-e053-2995a90a968f
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPharmPak, Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 7
- ndc1154348835001 BOTTLE in 1 BOX (54348-835-00) / 1 TABLET, FILM COATED in 1 BOTTLE
- ndc1154348835081 BOTTLE in 1 BOX (54348-835-08) / 8 TABLET, FILM COATED in 1 BOTTLE
- ndc1154348835101 BOTTLE in 1 BOX (54348-835-10) / 10 TABLET, FILM COATED in 1 BOTTLE
- ndc1154348835121 BOTTLE in 1 BOX (54348-835-12) / 12 TABLET, FILM COATED in 1 BOTTLE
- ndc1154348835201 BOTTLE in 1 BOX (54348-835-20) / 20 TABLET, FILM COATED in 1 BOTTLE
- ndc1154348835301 BOTTLE in 1 BOX (54348-835-30) / 30 TABLET, FILM COATED in 1 BOTTLE
- ndc1154348835601 BOTTLE in 1 BOX (54348-835-60) / 60 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A091625
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": "54348-835_eaa5cc60-19cc-a3f1-e053-2995a90a968f",
"productndc": "54348-835",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "091625",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "001",
"approval_date": "Sep 15, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "600MG",
"product_no": "002",
"approval_date": "Sep 15, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "003",
"approval_date": "Sep 15, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091625",
"marketing_category": "ANDA",
"nonproprietary_name": "IBUPROFEN",
"start_marketing_date": "20190711",
"active_numerator_strength": "400"
}Related drugs
Other records sharing ATC code G02CC01.
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