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 · 4

ndc11
4733566608
100 TABLET, FILM COATED in 1 BOTTLE (47335-666-08)
ndc11
4733566618
1000 TABLET, FILM COATED in 1 BOTTLE (47335-666-18)
ndc11
4733566683
30 TABLET, FILM COATED in 1 BOTTLE (47335-666-83)
ndc11
4733566688
100 TABLET, FILM COATED in 1 BOTTLE (47335-666-88)

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": "47335-666_a9910c38-e099-4f8a-a7e9-a88623be2032",
  "productndc": "47335-666",
  "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": "20151130",
  "active_numerator_strength": "5"
}

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