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United States · US · US:67979-001_25cb4a4a-e28a-c674-e063-6294a90a0bdd
Valstar
Orange BookUNIISPLATC L01DB09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEndo USA, Inc.
CountryUS (United States)
ATC codeL01DB09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1167979001014 VIAL in 1 CARTON (67979-001-01) / 5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
2C6NUM6878
VALRUBICIN
RxCUI 31435
Orange Book
N020892
AO
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2C6NUM6878",
"rxcui": "31435",
"inchikey": "ZOCKGBMQLCSHFP-KQRAQHLDSA-N",
"display_name": "VALRUBICIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVESICAL",
"spl_meta": {
"e96f30a0-6662-11de-8f80-0002a5d5c51b": {
"match": "brand_token",
"title": "VALSTAR (VALRUBICIN) SOLUTION, CONCENTRATE [ENDO USA, INC.]",
"spl_version": "38",
"published_date": "2024-11-04"
}
},
"productid": "67979-001_25cb4a4a-e28a-c674-e063-6294a90a0bdd",
"productndc": "67979-001",
"dosage_form": "SOLUTION, CONCENTRATE",
"orange_book": {
"appl_no": "020892",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AO",
"strength": "40MG/ML",
"product_no": "001",
"approval_date": "Sep 25, 1998"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VALRUBICIN",
"proprietary_name": "Valstar",
"active_ingred_unit": "mg/mL",
"application_number": "NDA020892",
"marketing_category": "NDA",
"nonproprietary_name": "valrubicin",
"start_marketing_date": "19981001",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code L01DB09.
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