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United States · US · US:68016-645_d2415143-02bb-4721-9d15-68833cbc7efb
Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChain Drug Consortium
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1168016645081 BOTTLE, PLASTIC in 1 CARTON (68016-645-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc1168016645121 BOTTLE, PLASTIC in 1 CARTON (68016-645-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- ndc1168016645151 BOTTLE, PLASTIC in 1 CARTON (68016-645-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A075010
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": "68016-645_d2415143-02bb-4721-9d15-68833cbc7efb",
"productndc": "68016-645",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "075010",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG",
"product_no": "001",
"approval_date": "Mar 1, 1999"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Ibuprofen",
"active_ingred_unit": "mg/1",
"application_number": "ANDA075010",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "19880524",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code G02CC01.
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