alendronate sodium

Generic: alendronate sodium

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alendronate sodium
Generic Name alendronate sodium
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alendronate sodium 70 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-633
Product ID 16714-633_fed80488-a7dd-4a81-b79a-75f10e71fa8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090124
Listing Expiration 2026-12-31
Marketing Start 2008-08-04

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714633
Hyphenated Format 16714-633

Supplemental Identifiers

RxCUI
904396 904419 904431
UPC
0316714631011 0316714631110
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
  • 70 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (16714-633-01) / 4 TABLET in 1 BLISTER PACK
  • 5 BLISTER PACK in 1 CARTON (16714-633-02) / 4 TABLET in 1 BLISTER PACK
  • 10 BLISTER PACK in 1 CARTON (16714-633-11) / 10 TABLET in 1 BLISTER PACK (16714-633-10)
source: ndc

Packages (3)

16714-633-01 1 BLISTER PACK in 1 CARTON (16714-633-01) / 4 TABLET in 1 BLISTER PACK 16714-633-02 5 BLISTER PACK in 1 CARTON (16714-633-02) / 4 TABLET in 1 BLISTER PACK 16714-633-11 10 BLISTER PACK in 1 CARTON (16714-633-11) / 10 TABLET in 1 BLISTER PACK (16714-633-10)

Ingredients (1)

alendronate sodium (70 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": "fed80488-a7dd-4a81-b79a-75f10e71fa8e", "openfda": {"upc": ["0316714631011", "0316714631110"], "unii": ["2UY4M2U3RA"], "rxcui": ["904396", "904419", "904431"], "spl_set_id": ["4323d3aa-cbb0-41e2-aba7-7a94a0516993"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (16714-633-01)  / 4 TABLET in 1 BLISTER PACK", "package_ndc": "16714-633-01", "marketing_start_date": "20080804"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (16714-633-02)  / 4 TABLET in 1 BLISTER PACK", "package_ndc": "16714-633-02", "marketing_start_date": "20080804"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (16714-633-11)  / 10 TABLET in 1 BLISTER PACK (16714-633-10)", "package_ndc": "16714-633-11", "marketing_start_date": "20080804"}], "brand_name": "Alendronate Sodium", "product_id": "16714-633_fed80488-a7dd-4a81-b79a-75f10e71fa8e", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "16714-633", "generic_name": "Alendronate Sodium", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alendronate Sodium", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "70 mg/1"}], "application_number": "ANDA090124", "marketing_category": "ANDA", "marketing_start_date": "20080804", "listing_expiration_date": "20261231"}