pamidronate disodium

Generic: pamidronate disodium

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pamidronate disodium
Generic Name pamidronate disodium
Labeler mylan institutional llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

pamidronate disodium 9 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-446
Product ID 67457-446_e3a78042-50cb-49d9-a31e-51d8edddbf4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078520
Listing Expiration 2027-12-31
Marketing Start 2011-05-10

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457446
Hyphenated Format 67457-446

Supplemental Identifiers

RxCUI
1737449 1737453
UNII
8742T8ZQZA

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pamidronate disodium (source: ndc)
Generic Name pamidronate disodium (source: ndc)
Application Number ANDA078520 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 9 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (67457-446-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

67457-446-10 1 VIAL in 1 CARTON (67457-446-10) / 10 mL in 1 VIAL

Ingredients (1)

pamidronate disodium (9 mg/mL)

Linked Drug Pages (1)

Pamidronate Disodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e3a78042-50cb-49d9-a31e-51d8edddbf4c", "openfda": {"unii": ["8742T8ZQZA"], "rxcui": ["1737449", "1737453"], "spl_set_id": ["c2ca033e-fa5f-4141-b702-11f8b4303da1"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (67457-446-10)  / 10 mL in 1 VIAL", "package_ndc": "67457-446-10", "marketing_start_date": "20110510"}], "brand_name": "Pamidronate Disodium", "product_id": "67457-446_e3a78042-50cb-49d9-a31e-51d8edddbf4c", "dosage_form": "INJECTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "67457-446", "generic_name": "Pamidronate Disodium", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pamidronate Disodium", "active_ingredients": [{"name": "PAMIDRONATE DISODIUM", "strength": "9 mg/mL"}], "application_number": "ANDA078520", "marketing_category": "ANDA", "marketing_start_date": "20110510", "listing_expiration_date": "20271231"}