risedronate sodium

Orange BookSPL

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4733592860
1 BLISTER PACK in 1 CARTON (47335-928-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
4733592867
3 BLISTER PACK in 1 CARTON (47335-928-67) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

Orange Book

A090886

ABABABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "47335-928_a9910c38-e099-4f8a-a7e9-a88623be2032",
  "productndc": "47335-928",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090886",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Nov 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Nov 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "35MG",
        "product_no": "003",
        "approval_date": "Nov 30, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "75MG",
        "product_no": "004",
        "approval_date": "Jun 10, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "005",
        "approval_date": "Jun 10, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RISEDRONATE SODIUM HEMI-PENTAHYDRATE",
  "proprietary_name": "risedronate sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090886",
  "marketing_category": "ANDA",
  "nonproprietary_name": "risedronate sodium",
  "start_marketing_date": "20140611",
  "active_numerator_strength": "150"
}

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