NDC 60429-643 Ibandronate Sodium
Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 60429 - Golden State Medical Supply, Inc.
- 60429-643 - Ibandronate Sodium
Product Characteristics
Product Packages
NDC Code 60429-643-73
Package Description: 3 BLISTER PACK in 1 PACKAGE / 1 TABLET, FILM COATED in 1 BLISTER PACK
Product Details
What is NDC 60429-643?
What are the uses for Ibandronate Sodium?
What are Ibandronate Sodium Active Ingredients?
- IBANDRONATE SODIUM 150 mg/1 - Aminobisphosphonate that is a potent inhibitor of BONE RESORPTION. It is used in the treatment of HYPERCALCEMIA associated with malignancy, for the prevention of fracture and bone complications in patients with breast cancer and bone metastases, and for the treatment and prevention of POSTMENOPAUSAL OSTEOPOROSIS.
Which are Ibandronate Sodium UNII Codes?
The UNII codes for the active ingredients in this product are:
- IBANDRONATE SODIUM (UNII: J12U072QL0)
- IBANDRONIC ACID (UNII: UMD7G2653W) (Active Moiety)
Which are Ibandronate 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:
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for Ibandronate Sodium?
- RxCUI: 904932 - ibandronate sodium 150 MG Oral Tablet
- RxCUI: 904932 - ibandronic acid 150 MG Oral Tablet
- RxCUI: 904932 - ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral Tablet
Which are the Pharmacologic Classes for Ibandronate Sodium?
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Patient Education
Ibandronate
Ibandronate is used to prevent and treat 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). Ibandronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".