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United States · US · US:66758-155_12a00376-75c0-41e4-b0a5-d8adb81a3cc4
Reclast
Orange BookUNIISPLATC M05BA08
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSandoz Inc
CountryUS (United States)
ATC codeM05BA08
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116675815546100 mL in 1 BOTTLE (66758-155-46)
Annotations
UNII (FDA Substance ID)
6XC1PAD3KF
ZOLEDRONIC ACID
RxCUI 77655
Orange Book
N021817
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6XC1PAD3KF",
"rxcui": "77655",
"inchikey": "FUXFIVRTGHOMSO-UHFFFAOYSA-N",
"display_name": "ZOLEDRONIC ACID",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"5a9b3737-9ce6-4a89-b76e-6aab79eba9cf": {
"match": "brand_token",
"title": "RECLAST (ZOLEDRONIC ACID) INJECTION, SOLUTION [SANDOZ INC]",
"spl_version": "3",
"published_date": "2026-02-13"
}
},
"productid": "66758-155_12a00376-75c0-41e4-b0a5-d8adb81a3cc4",
"productndc": "66758-155",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "021817",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "EQ 5MG BASE/100ML",
"product_no": "001",
"approval_date": "Apr 16, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZOLEDRONIC ACID",
"proprietary_name": "Reclast",
"active_ingred_unit": "mg/100mL",
"application_number": "NDA021817",
"marketing_category": "NDA",
"nonproprietary_name": "zoledronic acid",
"start_marketing_date": "20070401",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M05BA08.
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