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United States · US · US:60505-6097_63d90e35-b379-2511-e5fd-b75c1d1d5dde
Ibandronate Sodium
Orange BookUNIISPLATC M05BA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerApotex Corp.
CountryUS (United States)
ATC codeM05BA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1160505609701 SYRINGE, GLASS in 1 CARTON (60505-6097-0) / 3 mL in 1 SYRINGE, GLASS
Annotations
UNII (FDA Substance ID)
J12U072QL0
IBANDRONATE SODIUM
RxCUI 236916
Orange Book
A204222
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "J12U072QL0",
"rxcui": "236916",
"inchikey": "VBDRTGFACFYFCT-UHFFFAOYSA-M",
"display_name": "IBANDRONATE SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAVENOUS",
"spl_meta": {
"86c0b4ae-5e38-4efe-88af-50ac560e294f": {
"match": "brand_token",
"title": "IBANDRONATE SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]",
"spl_version": "12",
"published_date": "2026-03-26"
}
},
"productid": "60505-6097_63d90e35-b379-2511-e5fd-b75c1d1d5dde",
"productndc": "60505-6097",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "204222",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AP",
"strength": "EQ 3MG BASE/3ML",
"product_no": "001",
"approval_date": "Oct 16, 2015"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBANDRONATE SODIUM",
"proprietary_name": "Ibandronate Sodium",
"active_ingred_unit": "mg/3mL",
"application_number": "ANDA204222",
"marketing_category": "ANDA",
"nonproprietary_name": "ibandronate sodium",
"start_marketing_date": "20160113",
"active_numerator_strength": "3"
}Related drugs
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