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United States · US · US:60505-2795_31cdb988-ed22-4f0d-d1c2-8e89aae8c703
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
- ndc1160505279503 BLISTER PACK in 1 PACKAGE (60505-2795-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
J12U072QL0
IBANDRONATE SODIUM
RxCUI 236916
Orange Book
A078948
AB
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": "ORAL",
"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": "60505-2795_31cdb988-ed22-4f0d-d1c2-8e89aae8c703",
"productndc": "60505-2795",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078948",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Mar 19, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IBANDRONATE SODIUM",
"proprietary_name": "IBANDRONATE SODIUM",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078948",
"marketing_category": "ANDA",
"nonproprietary_name": "IBANDRONATE SODIUM",
"start_marketing_date": "20120319",
"active_numerator_strength": "150"
}Related drugs
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- PLBondronatAtnahs Pharma Netherlands B.V.
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