Alendronate Sodium
- Product NDC
- 0115-1680
- 11-digit product format
- 001151680
- Labeler code
- 0115
- Product ID
- 0115-1680_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alendronate Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA075710
- Marketing category
- ANDA
- Marketing start
- 2008-02-06
- Substance
- ALENDRONATE SODIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Alendronate Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALENDRONATE SODIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2UY4M2U3RA |
| Rxcui | 904396, 904405, 904419, 904425, 904431 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0115-1680-08 | Alendronate Sodium | 30 in 1 BOTTLE | TABLET | 30 | | 40 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0115-1680 | ALENDRONATE SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 40 | Current NDC, Legacy NDC, 1 package rows | 20231231_c23fb7fe-c6b9-4f77-bde7-992222b589d3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0115-1680-08 | 00115168008 | 30 TABLET in 1 BOTTLE (0115-1680-08) | 30 tablet | 2008-02-06 | 0000-00-00 | No | No | Current |