🇺🇸
United States · US · US:58602-839_8c55a203-6e1b-4f5b-9788-cde24942b6df
Ibuprofen and Pseudoephedrine Hydrochloride
Orange BookUNIISPLATC C01EB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeC01EB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1158602839134 BLISTER PACK in 1 CARTON (58602-839-13) / 8 TABLET, COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A213565
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": "58602-839_8c55a203-6e1b-4f5b-9788-cde24942b6df",
"productndc": "58602-839",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "213565",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG;30MG",
"product_no": "001",
"approval_date": "Mar 10, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Ibuprofen and Pseudoephedrine Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA213565",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibuprofen and Pseudoephedrine Hydrochloride",
"start_marketing_date": "20230310",
"active_numerator_strength": "200; 30"
}Related drugs
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