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United States · US · US:0299-3823_253c7c90-5d85-b1e0-e063-6394a90a7a4b
SOOLANTRA
Orange BookUNIISPLATC D11AX22
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGalderma Laboratories, L.P.
CountryUS (United States)
ATC codeD11AX22
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1102993823002 g in 1 TUBE (0299-3823-00)
- ndc1102993823021 TUBE in 1 BLISTER PACK (0299-3823-02) / 2 g in 1 TUBE
- ndc1102993823301 TUBE in 1 CARTON (0299-3823-30) / 30 g in 1 TUBE
- ndc1102993823451 TUBE in 1 CARTON (0299-3823-45) / 45 g in 1 TUBE
- ndc1102993823601 TUBE in 1 CARTON (0299-3823-60) / 60 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
8883YP2R6D
IVERMECTIN
RxCUI 6069
Orange Book
N206255
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "8883YP2R6D",
"rxcui": "6069",
"inchikey": null,
"display_name": "IVERMECTIN",
"substance_type": "mixture",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"b1d5b166-ab06-4ab5-b0c6-31126238118a": {
"match": "brand_token",
"title": "SOOLANTRA (IVERMECTIN) CREAM [GALDERMA LABORATORIES, L.P.]",
"spl_version": "8",
"published_date": "2024-10-28"
}
},
"productid": "0299-3823_253c7c90-5d85-b1e0-e063-6394a90a7a4b",
"productndc": "0299-3823",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "206255",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "1%",
"product_no": "001",
"approval_date": "Dec 19, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IVERMECTIN",
"proprietary_name": "SOOLANTRA",
"active_ingred_unit": "mg/g",
"application_number": "NDA206255",
"marketing_category": "NDA",
"nonproprietary_name": "IVERMECTIN",
"start_marketing_date": "20150101",
"active_numerator_strength": "10"
}Related drugs
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