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United States · US · US:60505-6414_1aaa2d67-c709-f01c-026d-0eaa8f47c5d1
IVRA
Orange BookUNIISPLATC L01AA03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp
CountryUS (United States)
ATC codeL01AA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160505641411 VIAL, MULTI-DOSE in 1 CARTON (60505-6414-1) / 3 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
1VXP4V453T
MELPHALAN HYDROCHLORIDE
RxCUI 235857
Orange Book
N217110
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "1VXP4V453T",
"rxcui": "235857",
"inchikey": "OUUYBRCCFUEMLH-YDALLXLXSA-N",
"display_name": "MELPHALAN HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"c23e868a-dc62-2181-5099-76c9226602b2": {
"match": "brand_token",
"title": "IVRA (MELPHALAN HCL) INJECTION, SOLUTION [APOTEX CORP]",
"spl_version": "5",
"published_date": "2025-09-08"
}
},
"productid": "60505-6414_1aaa2d67-c709-f01c-026d-0eaa8f47c5d1",
"productndc": "60505-6414",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "217110",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 90MG BASE/ML (EQ 90MG BASE/ML)",
"product_no": "001",
"approval_date": "Aug 18, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "MELPHALAN HYDROCHLORIDE",
"proprietary_name": "IVRA",
"active_ingred_unit": "mg/mL",
"application_number": "NDA217110",
"marketing_category": "NDA",
"nonproprietary_name": "melphalan HCl",
"start_marketing_date": "20250509",
"active_numerator_strength": "90"
}Related drugs
Other records sharing ATC code L01AA03.
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