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United States · US · US:33342-107_56e83e0f-83f7-4039-a9b2-0d5ae251e2b1
Risedronate Sodium
Orange BookUNIISPLATC M05BA07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeM05BA07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1133342107063 BLISTER PACK in 1 CARTON (33342-107-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK
- ndc11333421070730 TABLET, FILM COATED in 1 CONTAINER (33342-107-07)
- ndc1133342107492000 TABLET, FILM COATED in 1 CONTAINER (33342-107-49)
Annotations
UNII (FDA Substance ID)
OFG5EXG60L
RISEDRONATE SODIUM
RxCUI 60334
Orange Book
A203533
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "OFG5EXG60L",
"rxcui": "60334",
"inchikey": "DRFDPXKCEWYIAW-UHFFFAOYSA-M",
"display_name": "RISEDRONATE SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c89430be-15f1-4b8b-ab7e-738de716ee7d": {
"match": "brand_token",
"title": "RISEDRONATE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS, INC.]",
"spl_version": "7",
"published_date": "2026-05-21"
}
},
"productid": "33342-107_56e83e0f-83f7-4039-a9b2-0d5ae251e2b1",
"productndc": "33342-107",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203533",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Dec 9, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "002",
"approval_date": "Dec 9, 2015"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "35MG",
"product_no": "003",
"approval_date": "Nov 29, 2016"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "RISEDRONATE SODIUM",
"proprietary_name": "Risedronate Sodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203533",
"marketing_category": "ANDA",
"nonproprietary_name": "Risedronate Sodium",
"start_marketing_date": "20151209",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code M05BA07.
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