Risedronate Sodium

Orange BookUNIISPLATC M05BA07

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeM05BA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6586251904
1 BLISTER PACK in 1 CARTON (65862-519-04) / 4 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6586251908
3 BLISTER PACK in 1 CARTON (65862-519-08) / 4 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

OFG5EXG60L

RISEDRONATE SODIUM

RxCUI 60334

Orange Book

A200296

ABABAB

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": "65862-519_9488209f-f3ad-4726-be89-f6a7e59e6885",
  "productndc": "65862-519",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "200296",
    "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"
      }
    ],
    "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": "ANDA200296",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Risedronate Sodium",
  "start_marketing_date": "20151130",
  "active_numerator_strength": "35"
}

Related drugs

Other records sharing ATC code M05BA07.

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