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United States · US · US:0430-0979_936662af-4e07-4361-b7ef-760ebfad3e01

Atelvia

Orange BookUNIISPL

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

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0430097903
    4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)

Annotations

UNII (FDA Substance ID)
HU2YAQ274O
RISEDRONATE SODIUM HEMIPENTAHYDRATE
RxCUI 1356127
Orange Book
N022560
AB
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": {
    "c8b9ab88-1a26-46c3-80ec-4eaa45202021": {
      "match": "brand_token",
      "title": "ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [ALLERGAN, INC.]",
      "spl_version": "29",
      "published_date": "2026-05-20"
    }
  },
  "productid": "0430-0979_936662af-4e07-4361-b7ef-760ebfad3e01",
  "productndc": "0430-0979",
  "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": "Atelvia",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022560",
  "marketing_category": "NDA",
  "nonproprietary_name": "risedronate sodium",
  "start_marketing_date": "20101201",
  "active_numerator_strength": "30.1; 4.9"
}

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