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United States · US · US:24338-050_288ecd1b-0244-dd13-e063-6394a90a739d
Gliadel
Orange BookUNIISPLATC L01AD01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL01AD01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1124338050088 POUCH in 1 BOX (24338-050-08) / 1 WAFER in 1 POUCH
Annotations
UNII (FDA Substance ID)
U68WG3173Y
CARMUSTINE
RxCUI 2105
Orange Book
N020637
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "U68WG3173Y",
"rxcui": "2105",
"inchikey": "DLGOEMSEDOSKAD-UHFFFAOYSA-N",
"display_name": "CARMUSTINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRACAVITARY",
"spl_meta": {
"38962a55-a514-4c48-bea5-f99a8da4beec": {
"match": "brand_token",
"title": "GLIADEL (CARMUSTINE) WAFER [AZURITY PHARMACEUTICALS, INC.]",
"spl_version": "8",
"published_date": "2024-12-09"
}
},
"productid": "24338-050_288ecd1b-0244-dd13-e063-6394a90a739d",
"productndc": "24338-050",
"dosage_form": "WAFER",
"orange_book": {
"appl_no": "020637",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "7.7MG",
"product_no": "001",
"approval_date": "Sep 23, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CARMUSTINE",
"proprietary_name": "Gliadel",
"active_ingred_unit": "mg/1",
"application_number": "NDA020637",
"marketing_category": "NDA",
"nonproprietary_name": "carmustine",
"start_marketing_date": "20121213",
"active_numerator_strength": "7.7"
}Related drugs
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