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United States · US · US:68094-503_569c23f2-55ee-4921-80ca-9362c8ce58b6
Childrens Ibuprofen
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrecision Dose Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11680945036110 TRAY in 1 CASE (68094-503-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)
- ndc1168094503623 TRAY in 1 CASE (68094-503-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-503-59)
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A074937
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": {
"436c0126-4ff3-c082-e063-6294a90a3d72": {
"match": "brand_token",
"title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
"spl_version": "2",
"published_date": "2026-06-01"
}
},
"productid": "68094-503_569c23f2-55ee-4921-80ca-9362c8ce58b6",
"productndc": "68094-503",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "074937",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG/5ML",
"product_no": "001",
"approval_date": "Dec 22, 1998"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Childrens Ibuprofen",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA074937",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20060914",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code G02CC01.
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