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United States · US · US:65862-870_bb13e9ba-84fc-41b6-b2f9-bedd9f3eef1f

Risedronate Sodium

Orange BookUNIISPLATC M05BA07

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeM05BA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6586287003
    1 BLISTER PACK in 1 CARTON (65862-870-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6586287011
    1 BLISTER PACK in 1 CARTON (65862-870-11) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
OFG5EXG60L
RISEDRONATE SODIUM
RxCUI 60334
Orange Book
A206768
AB
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": "65862-870_bb13e9ba-84fc-41b6-b2f9-bedd9f3eef1f",
  "productndc": "65862-870",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "206768",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Oct 21, 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": "ANDA206768",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Risedronate Sodium",
  "start_marketing_date": "20161021",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code M05BA07.

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