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United States · US · US:55111-575_eeeb1802-6fe6-ebb0-2df8-98b42385b89f
Ibandronate sodium
Orange BookUNIISPLATC M05BA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy's Laboratories Limited
CountryUS (United States)
ATC codeM05BA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1155111575033 BLISTER PACK in 1 CARTON (55111-575-03) / 1 TABLET in 1 BLISTER PACK (55111-575-11)
- ndc1155111575431 BLISTER PACK in 1 CARTON (55111-575-43) / 3 TABLET in 1 BLISTER PACK (55111-575-13)
Annotations
UNII (FDA Substance ID)
J12U072QL0
IBANDRONATE SODIUM
RxCUI 236916
Orange Book
A078997
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": "55111-575_eeeb1802-6fe6-ebb0-2df8-98b42385b89f",
"productndc": "55111-575",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078997",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "EQ 150MG BASE",
"product_no": "001",
"approval_date": "Apr 30, 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": "ANDA078997",
"marketing_category": "ANDA",
"nonproprietary_name": "Ibandronate sodium",
"start_marketing_date": "20120621",
"active_numerator_strength": "150"
}Related drugs
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- DKBondronatAtnahs Pharma Netherlands B.V.
- ISBondronatAtnahs Pharma Netherlands B.V.
- PLBondronatAtnahs Pharma Netherlands B.V.
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