alendronate sodium

Generic: alendronate sodium

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

Drug Facts

Product Profile

Brand Name alendronate sodium
Generic Name alendronate sodium
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

alendronate sodium 70 mg/75mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0282
Product ID 0054-0282_56e063a8-8c3d-4445-91fd-0c8806c2b127
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090520
Listing Expiration 2027-12-31
Marketing Start 2020-10-30

Pharmacologic Class

Classes
bisphosphonate [epc] diphosphonates [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540282
Hyphenated Format 0054-0282

Supplemental Identifiers

RxCUI
904447
UPC
0300540282592
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 ANDA090520 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 70 mg/75mL
source: ndc
Packaging
  • 4 BOTTLE, UNIT-DOSE in 1 CARTON (0054-0282-59) / 75 mL in 1 BOTTLE, UNIT-DOSE
source: ndc

Packages (1)

0054-0282-59 4 BOTTLE, UNIT-DOSE in 1 CARTON (0054-0282-59) / 75 mL in 1 BOTTLE, UNIT-DOSE

Ingredients (1)

alendronate sodium (70 mg/75mL)

Linked Drug Pages (1)

Alendronate Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "56e063a8-8c3d-4445-91fd-0c8806c2b127", "openfda": {"upc": ["0300540282592"], "unii": ["2UY4M2U3RA"], "rxcui": ["904447"], "spl_set_id": ["c910bb05-279b-4ffa-a867-46f4a0853ed5"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BOTTLE, UNIT-DOSE in 1 CARTON (0054-0282-59)  / 75 mL in 1 BOTTLE, UNIT-DOSE", "package_ndc": "0054-0282-59", "marketing_start_date": "20201030"}], "brand_name": "Alendronate Sodium", "product_id": "0054-0282_56e063a8-8c3d-4445-91fd-0c8806c2b127", "dosage_form": "SOLUTION", "pharm_class": ["Bisphosphonate [EPC]", "Diphosphonates [CS]"], "product_ndc": "0054-0282", "generic_name": "Alendronate Sodium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alendronate Sodium", "active_ingredients": [{"name": "ALENDRONATE SODIUM", "strength": "70 mg/75mL"}], "application_number": "ANDA090520", "marketing_category": "ANDA", "marketing_start_date": "20201030", "listing_expiration_date": "20271231"}