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NDC 00115-1678-01 Alendronate Sodium 10 mg/1 Details
Alendronate Sodium 10 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.
Product Information
NDC | 00115-1678 |
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Product ID | 0115-1678_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1 |
Associated GPIs | 30042010100310 |
GCN Sequence Number | 024053 |
GCN Sequence Number Description | alendronate sodium TABLET 10 MG ORAL |
HIC3 | P4L |
HIC3 Description | BONE RESORPTION INHIBITORS |
GCN | 21680 |
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 | 10 |
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 00115-1678-01 (00115167801)
NDC Package Code | 0115-1678-01 |
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Billing NDC | 00115167801 |
Package | 100 TABLET in 1 BOTTLE (0115-1678-01) |
Marketing Start Date | 2008-02-06 |
NDC Exclude Flag | N |
Pricing Information | N/A |