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United States · US · US:61269-527_33920aab-2fdc-44ed-b36d-0d759a9bcd94
Childrens Allergy
Orange BookUNIISPLATC R06AX26
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerH2-Pharma, LLC
CountryUS (United States)
ATC codeR06AX26
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1161269527941 BOTTLE in 1 CARTON (61269-527-94) / 118 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A203330
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2S068B75ZU",
"rxcui": "236474",
"inchikey": "RRJFVPUCXDGFJB-UHFFFAOYSA-N",
"display_name": "FEXOFENADINE HYDROCHLORIDE",
"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": "61269-527_33920aab-2fdc-44ed-b36d-0d759a9bcd94",
"productndc": "61269-527",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "203330",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG/5ML",
"product_no": "001",
"approval_date": "Nov 18, 2014"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "30MG/5ML",
"product_no": "002",
"approval_date": "Nov 18, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "FEXOFENADINE HYDROCHLORIDE",
"proprietary_name": "Childrens Allergy",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA203330",
"marketing_category": "ANDA",
"nonproprietary_name": "fexofenadine hydrochloride",
"start_marketing_date": "20220718",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code R06AX26.
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