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NDC 00115-1676-01 Alendronate Sodium 5 mg/1 Details
Alendronate Sodium 5 mg/1
Alendronate Sodium is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is ALENDRONATE SODIUM.
MedlinePlus Drug Summary
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).
Related Packages: 00115-1676-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Alendronate
Product Information
| NDC | 00115-1676 |
|---|---|
| Product ID | 0115-1676_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1 |
| Associated GPIs | 30042010100305 |
| GCN Sequence Number | 031006 |
| GCN Sequence Number Description | alendronate sodium TABLET 5 MG ORAL |
| HIC3 | P4L |
| HIC3 Description | BONE RESORPTION INHIBITORS |
| GCN | 21682 |
| HICL Sequence Number | 010124 |
| HICL Sequence Number Description | ALENDRONATE SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Alendronate Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Alendronate Sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | ALENDRONATE SODIUM |
| Labeler Name | Amneal Pharmaceuticals of New York LLC |
| Pharmaceutical Class | Bisphosphonate [EPC], Diphosphonates [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075710 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00115-1676-01 (00115167601)
| NDC Package Code | 0115-1676-01 |
|---|---|
| Billing NDC | 00115167601 |
| Package | 100 TABLET in 1 BOTTLE (0115-1676-01) |
| Marketing Start Date | 2008-02-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |