Risedronate Sodium

Orange BookUNIISPL

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

Identification

ManufacturerMylan Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5976204074
4 TABLET, DELAYED RELEASE in 1 DOSE PACK (59762-0407-4)

Annotations

UNII (FDA Substance ID)

HU2YAQ274O

RISEDRONATE SODIUM HEMIPENTAHYDRATE

RxCUI 1356127

Orange Book

N022560

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "HU2YAQ274O",
    "rxcui": "1356127",
    "inchikey": "HYFDYHPNTXOPPO-UHFFFAOYSA-L",
    "display_name": "RISEDRONATE SODIUM HEMIPENTAHYDRATE",
    "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": "59762-0407_b7e3ea01-4634-467a-b087-3d52ef7af465",
  "productndc": "59762-0407",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "022560",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "35MG",
        "product_no": "001",
        "approval_date": "Oct 8, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RISEDRONATE SODIUM HEMIPENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE",
  "proprietary_name": "Risedronate Sodium",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022560",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "risedronate sodium",
  "start_marketing_date": "20180302",
  "active_numerator_strength": "30.1; 4.9"
}

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