RISEDRONATE SODIUM

Orange BookUNIISPLATC M05BA07

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

Identification

ManufacturerSun Pharmaceutical Industires Inc.

CountryUS (United States)

ATC codeM05BA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6330444009
1 DOSE PACK in 1 CARTON (63304-440-09) / 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11)

Annotations

UNII (FDA Substance ID)

OFG5EXG60L

RISEDRONATE SODIUM

RxCUI 60334

Orange Book

A203925

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": "63304-440_d97c9e6a-01e9-46ae-9088-0ca86b4eb842",
  "productndc": "63304-440",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "203925",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "35MG",
        "product_no": "001",
        "approval_date": "Jul 9, 2019"
      }
    ],
    "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": "ANDA203925",
  "marketing_category": "ANDA",
  "nonproprietary_name": "RISEDRONATE SODIUM",
  "start_marketing_date": "20190710",
  "active_numerator_strength": "35"
}

Related drugs

Other records sharing ATC code M05BA07.

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