alendronate sodium

Generic: alendronate sodium

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alendronate sodium
Generic Name alendronate sodium
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alendronate sodium 35 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-328
Product ID 65862-328_2823474d-dfc5-4eee-81cd-352f913990d7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090124
Listing Expiration 2027-12-31
Marketing Start 2008-08-04

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862328
Hyphenated Format 65862-328

Supplemental Identifiers

RxCUI
904396 904419 904431
UPC
0365862329011
UNII
2UY4M2U3RA

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 alendronate sodium (source: ndc)
Generic Name alendronate sodium (source: ndc)
Application Number ANDA090124 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 35 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (65862-328-04) / 4 TABLET in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (65862-328-08) / 4 TABLET in 1 BLISTER PACK
  • 10 BLISTER PACK in 1 CARTON (65862-328-10) / 10 TABLET in 1 BLISTER PACK
  • 5 BLISTER PACK in 1 CARTON (65862-328-20) / 4 TABLET in 1 BLISTER PACK
source: ndc

Packages (4)

65862-328-04 1 BLISTER PACK in 1 CARTON (65862-328-04) / 4 TABLET in 1 BLISTER PACK 65862-328-08 3 BLISTER PACK in 1 CARTON (65862-328-08) / 4 TABLET in 1 BLISTER PACK 65862-328-10 10 BLISTER PACK in 1 CARTON (65862-328-10) / 10 TABLET in 1 BLISTER PACK 65862-328-20 5 BLISTER PACK in 1 CARTON (65862-328-20) / 4 TABLET in 1 BLISTER PACK

Ingredients (1)

alendronate sodium (35 mg/1)

Linked Drug Pages (1)

Alendronate Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2823474d-dfc5-4eee-81cd-352f913990d7", "openfda": {"upc": ["0365862329011"], "unii": ["2UY4M2U3RA"], "rxcui": ["904396", "904419", "904431"], "spl_set_id": ["815a87c4-e489-4eb9-9a2e-fb7a16642f01"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (65862-328-04)  / 4 TABLET in 1 BLISTER PACK", "package_ndc": "65862-328-04", "marketing_start_date": "20080804"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-328-08)  / 4 TABLET in 1 BLISTER PACK", "package_ndc": "65862-328-08", "marketing_start_date": "20080804"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-328-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "65862-328-10", "marketing_start_date": "20080804"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (65862-328-20)  / 4 TABLET in 1 BLISTER PACK", "package_ndc": "65862-328-20", "marketing_start_date": "20080804"}], "brand_name": "Alendronate Sodium", "product_id": "65862-328_2823474d-dfc5-4eee-81cd-352f913990d7", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "65862-328", "generic_name": "Alendronate Sodium", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alendronate Sodium", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "35 mg/1"}], "application_number": "ANDA090124", "marketing_category": "ANDA", "marketing_start_date": "20080804", "listing_expiration_date": "20271231"}