alendronate sodium

Generic: alendronate sodium

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alendronate sodium
Generic Name alendronate sodium
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

alendronate sodium 70 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-224
Product ID 69097-224_1d9a10b4-dc2b-4d58-902a-f202535f4b11
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076768
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 69097224
Hyphenated Format 69097-224

Supplemental Identifiers

RxCUI
904396 904431
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 ANDA076768 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 70 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (69097-224-76) / 4 TABLET in 1 BLISTER PACK (69097-224-16)
source: ndc

Packages (1)

69097-224-76 3 BLISTER PACK in 1 CARTON (69097-224-76) / 4 TABLET in 1 BLISTER PACK (69097-224-16)

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": "1d9a10b4-dc2b-4d58-902a-f202535f4b11", "openfda": {"unii": ["2UY4M2U3RA"], "rxcui": ["904396", "904431"], "spl_set_id": ["e2fac28d-ad91-4cdc-a003-9fdeac073f76"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (69097-224-76)  / 4 TABLET in 1 BLISTER PACK (69097-224-16)", "package_ndc": "69097-224-76", "marketing_start_date": "20080804"}], "brand_name": "ALENDRONATE SODIUM", "product_id": "69097-224_1d9a10b4-dc2b-4d58-902a-f202535f4b11", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "69097-224", "generic_name": "Alendronate sodium", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALENDRONATE SODIUM", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "70 mg/1"}], "application_number": "ANDA076768", "marketing_category": "ANDA", "marketing_start_date": "20080804", "listing_expiration_date": "20271231"}