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United States · US · US:24201-101_f2385edd-45ba-4ce8-97a0-ac301d067536
Valrubicin Intravesical Solution
Orange BookUNIIATC L01DB09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeL01DB09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1124201101044 VIAL in 1 CARTON (24201-101-04) / 5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
2C6NUM6878
VALRUBICIN
RxCUI 31435
Orange Book
A206430
AO
Raw payload (JSON)
{
"unii": {
"unii": "2C6NUM6878",
"rxcui": "31435",
"inchikey": "ZOCKGBMQLCSHFP-KQRAQHLDSA-N",
"display_name": "VALRUBICIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVESICAL",
"productid": "24201-101_f2385edd-45ba-4ce8-97a0-ac301d067536",
"productndc": "24201-101",
"dosage_form": "SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "206430",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AO",
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Apr 19, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALRUBICIN",
"proprietary_name": "Valrubicin Intravesical Solution",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA206430",
"marketing_category": "ANDA",
"nonproprietary_name": "Valrubicin Intravesical Solution",
"start_marketing_date": "20190423",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L01DB09.
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