NDC 10135-696 Alendronate

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
10135-696
Proprietary Name:
Alendronate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Marlex Pharmaceuticals Inc
Labeler Code:
10135
Start Marketing Date: [9]
03-01-2020
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
OVAL (C48345)
Size(s):
13 MM
Imprint(s):
AP207
Score:
1

Product Packages

NDC Code 10135-696-12

Package Description: 3 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK

NDC Code 10135-696-44

Package Description: 1 BLISTER PACK in 1 CARTON / 4 TABLET in 1 BLISTER PACK

Product Details

What is NDC 10135-696?

The NDC code 10135-696 is assigned by the FDA to the product Alendronate which is product labeled by Marlex Pharmaceuticals Inc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 10135-696-12 3 blister pack in 1 carton / 4 tablet in 1 blister pack, 10135-696-44 1 blister pack in 1 carton / 4 tablet in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Alendronate?

Alendronate sodium tablets are contraindicated in patients with the following conditions:Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [see Warnings and Precautions (5.1)]Inability to stand or sit upright for at least 30 minutes [see Dosage and Administration (2.6); Warnings and Precautions (5.1)]Hypocalcemia [see Warnings and Precautions (5.2)]Hypersensitivity to any component of this product. Hypersensitivity reactions including urticaria and angioedema have been reported [see Adverse Reactions (6.2)].

Which are Alendronate UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Alendronate 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:

What is the NDC to RxNorm Crosswalk for Alendronate?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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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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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[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".