Risedronate Sodium

Orange BookUNIISPLATC M05BA07

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerApotex Corp.

CountryUS (United States)

ATC codeM05BA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6050530962
1 BLISTER PACK in 1 CARTON (60505-3096-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

OFG5EXG60L

RISEDRONATE SODIUM

RxCUI 60334

Orange Book

A090877

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": "60505-3096_03750616-5c88-729a-215e-3d796f8ba6a8",
  "productndc": "60505-3096",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090877",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "35MG",
        "product_no": "001",
        "approval_date": "Nov 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "002",
        "approval_date": "Jun 10, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Jun 10, 2014"
      }
    ],
    "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": "ANDA090877",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Risedronate Sodium",
  "start_marketing_date": "20140611",
  "active_numerator_strength": "75"
}

Related drugs

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