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United States · US · US:78670-150_5b900700-64d3-4f68-834a-2a71f5216a46
iwilfin
Orange BookUNIISPLATC D11AX16
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUSWM, LLC
CountryUS (United States)
ATC codeD11AX16
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1178670150011 BOTTLE in 1 CARTON (78670-150-01) / 100 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
4NH22NDW9H
EFLORNITHINE HYDROCHLORIDE
RxCUI 81945
Orange Book
N215500
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4NH22NDW9H",
"rxcui": "81945",
"inchikey": "FJPAMFNRCFEGSD-UHFFFAOYSA-N",
"display_name": "EFLORNITHINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"6716d8cc-66e6-4cee-935c-ccb85ed984f5": {
"match": "brand_token",
"title": "IWILFIN (EFLORNITHINE HYDROCHLORIDE) TABLET [USWM, LLC]",
"spl_version": "7",
"published_date": "2026-03-30"
}
},
"productid": "78670-150_5b900700-64d3-4f68-834a-2a71f5216a46",
"productndc": "78670-150",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215500",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 192MG BASE",
"product_no": "001",
"approval_date": "Dec 13, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "EFLORNITHINE HYDROCHLORIDE",
"proprietary_name": "iwilfin",
"active_ingred_unit": "mg/1",
"application_number": "NDA215500",
"marketing_category": "NDA",
"nonproprietary_name": "EFLORNITHINE HYDROCHLORIDE",
"start_marketing_date": "20240115",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code D11AX16.
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