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United States · US · US:71469-231_957499a8-90f5-4cbd-916d-abfd8251e1b4
GLEOLAN
Orange BookUNIISPLATC L01XD04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNX DEVELOPMENT CORP
CountryUS (United States)
ATC codeL01XD04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171469231011 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
V35KBM8JGR
AMINOLEVULINIC ACID HYDROCHLORIDE
RxCUI 261715
Orange Book
N208630
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "V35KBM8JGR",
"rxcui": "261715",
"inchikey": "ZLHFONARZHCSET-UHFFFAOYSA-N",
"display_name": "AMINOLEVULINIC ACID HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"cdeded66-0017-42cf-9471-13f231014323": {
"match": "brand_token",
"title": "GLEOLAN (AMINOLEVULINIC ACID HYDROCHLORIDE) POWDER, FOR SOLUTION [NX DEVELOPMENT CORP]",
"spl_version": "8",
"published_date": "2026-02-02"
}
},
"productid": "71469-231_957499a8-90f5-4cbd-916d-abfd8251e1b4",
"productndc": "71469-231",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "208630",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1.5GM/VIAL",
"product_no": "001",
"approval_date": "Jun 6, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AMINOLEVULINIC ACID HYDROCHLORIDE",
"proprietary_name": "GLEOLAN",
"active_ingred_unit": "mg/1",
"application_number": "NDA208630",
"marketing_category": "NDA",
"nonproprietary_name": "AMINOLEVULINIC ACID HYDROCHLORIDE",
"start_marketing_date": "20180314",
"active_numerator_strength": "1500"
}Related drugs
Other records sharing ATC code L01XD04.
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