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United States · US · US:69452-378_7c860070-7f7a-4217-9cfb-f5536fd736b4
IBANDRONATE SODIUM
Orange BookUNIISPLATC M05BA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeM05BA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1169452378741 BLISTER PACK in 1 CARTON (69452-378-74) / 3 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
J12U072QL0
IBANDRONATE SODIUM
RxCUI 236916
Orange Book
A078998
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": "69452-378_7c860070-7f7a-4217-9cfb-f5536fd736b4",
"productndc": "69452-378",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078998",
"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": "ANDA078998",
"marketing_category": "ANDA",
"nonproprietary_name": "IBANDRONATE SODIUM",
"start_marketing_date": "20230526",
"active_numerator_strength": "150"
}Related drugs
Other records sharing ATC code M05BA06.
- DKBaxogarPharmathen S.A.
- NLBaxogar 150 mg filmomhulde tablettenPharmathen S.A.
- FIBondenzaRoche Registration Limited
- FIBondenzaRoche Registration Limited
- FIBondenzaRoche Registration Limited
- DKBondronatAtnahs Pharma Netherlands B.V.
- ISBondronatAtnahs Pharma Netherlands B.V.
- PLBondronatAtnahs Pharma Netherlands B.V.
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