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United States · US · US:83324-005_c9ae72d8-d205-4736-9bc4-2325cd77d36b
Concentrated ibuprofen infants
Orange BookUNIISPLATC G02CC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChain Drug Marketing Association Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1183324005301 BOTTLE in 1 CARTON (83324-005-30) / 30 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A210755
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": {
"c9ae72d8-d205-4736-9bc4-2325cd77d36b": {
"match": "brand_token",
"title": "CONCENTRATED IBUPROFEN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC.]",
"spl_version": "1",
"published_date": "2023-11-08"
}
},
"productid": "83324-005_c9ae72d8-d205-4736-9bc4-2325cd77d36b",
"productndc": "83324-005",
"dosage_form": "SUSPENSION/ DROPS",
"orange_book": {
"appl_no": "210755",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Sep 26, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN",
"proprietary_name": "Concentrated ibuprofen infants",
"active_ingred_unit": "mg/1.25mL",
"application_number": "ANDA210755",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen",
"start_marketing_date": "20231103",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code G02CC01.
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