NDC 61919-689 Alendronate Sodium
View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Get all the details for National Drug Code (NDC) 61919-689 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.
Product Characteristics
Code Structure Chart
Product Details
What is NDC 61919-689?
What are the uses for Alendronate Sodium?
Which are Alendronate Sodium UNII Codes?
The UNII codes for the active ingredients in this product are:
- ALENDRONATE SODIUM (UNII: 2UY4M2U3RA)
- ALENDRONIC ACID (UNII: X1J18R4W8P) (Active Moiety)
Which are Alendronate Sodium Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- MANNITOL (UNII: 3OWL53L36A)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
- STARCH, CORN (UNII: O8232NY3SJ)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
What is the NDC to RxNorm Crosswalk for Alendronate Sodium?
- RxCUI: 904431 - alendronate sodium 70 MG Oral Tablet
- RxCUI: 904431 - alendronic acid 70 MG Oral Tablet
- RxCUI: 904431 - alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet
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Patient Education
Alendronate
Alendronate is used to treat and prevent osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause (''change of life,'' end of menstrual periods) and to treat osteoporosis in men. Alendronate is also used to treat osteoporosis in men and women who are taking corticosteroids (a type of medication that may cause osteoporosis in some patients). Alendronate is also used to treat Paget's disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Alendronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).
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[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".