alendronate sodium

Generic: alendronate sodium

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

Drug Facts

Product Profile

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

alendronate sodium 35 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-1192
Product ID 70518-1192_48c078c8-eb3f-84f4-e063-6394a90a8699
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076768
Listing Expiration 2027-12-31
Marketing Start 2018-05-16

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705181192
Hyphenated Format 70518-1192

Supplemental Identifiers

RxCUI
904396
UNII
2UY4M2U3RA

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
  • 35 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (70518-1192-1) / 4 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

70518-1192-1 3 BLISTER PACK in 1 CARTON (70518-1192-1) / 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": "48c078c8-eb3f-84f4-e063-6394a90a8699", "openfda": {"unii": ["2UY4M2U3RA"], "rxcui": ["904396"], "spl_set_id": ["c7e470d6-508e-466e-a78d-060bbbc9745c"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (70518-1192-1)  / 4 TABLET in 1 BLISTER PACK", "package_ndc": "70518-1192-1", "marketing_start_date": "20240112"}], "brand_name": "ALENDRONATE SODIUM", "product_id": "70518-1192_48c078c8-eb3f-84f4-e063-6394a90a8699", "dosage_form": "TABLET", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "70518-1192", "generic_name": "Alendronate sodium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ALENDRONATE SODIUM", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "35 mg/1"}], "application_number": "ANDA076768", "marketing_category": "ANDA", "marketing_start_date": "20180516", "listing_expiration_date": "20271231"}