Pamidronate Disodium

Orange BookUNIISPLATC M05BA03

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

Identification

ManufacturerMylan Institutional LLC

CountryUS (United States)

ATC codeM05BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6745743010
1 VIAL in 1 CARTON (67457-430-10) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

8742T8ZQZA

PAMIDRONATE DISODIUM

RxCUI 105443

Orange Book

A078520

AP2AP2

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "8742T8ZQZA",
    "rxcui": "105443",
    "inchikey": "CZYWHNTUXNGDGR-UHFFFAOYSA-L",
    "display_name": "PAMIDRONATE DISODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23": {
      "match": "brand_token",
      "title": "PAMIDRONATE DISODIUM INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "24",
      "published_date": "2026-05-15"
    }
  },
  "productid": "67457-430_e3a78042-50cb-49d9-a31e-51d8edddbf4c",
  "productndc": "67457-430",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "078520",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP2",
        "strength": "30MG/10ML (3MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 31, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP2",
        "strength": "90MG/10ML (9MG/ML)",
        "product_no": "002",
        "approval_date": "Oct 31, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PAMIDRONATE DISODIUM",
  "proprietary_name": "Pamidronate Disodium",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078520",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pamidronate Disodium",
  "start_marketing_date": "20110510",
  "active_numerator_strength": "3"
}

Related drugs

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