ALENDRONATE SODIUM
- Product NDC
- 68071-3340
- 11-digit product format
- 680713340
- Labeler code
- 68071
- Product ID
- 68071-3340_1cd71696-d95a-be3e-e063-6394a90a28c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alendronate sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA076768
- Marketing category
- ANDA
- Marketing start
- 2008-08-04
- Substance
- ALENDRONATE SODIUM
- Active strength
- 70 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALENDRONATE SODIUM | 70 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2UY4M2U3RA |
| Rxcui | 904431 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-3340-4 | 2024-07-09 | C162847 | 48780-1 | ba0f9c33-1cdc-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995 |
| 68071-3340-4 | 2024-07-09 | C162847 | 48780-1 | ba0f9c33-1cdc-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995 |
| 68071-3340-4 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1cdc-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995 |
| 68071-3340-4 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1cdc-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995 |
| 68071-3340-4 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-1cdc-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995 |
| 68071-3340-4 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-1cdc-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995 |
| 68071-3340-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1cdc-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995 |
| 68071-3340-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1cdc-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3340-4 | ALENDRONATE SODIUM | 4 in 1 BOX | TABLET | 4 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3340 | ALENDRONATE SODIUM TABLET [NUCARE PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240711_54d6543d-4239-58b1-e054-00144ff88e88.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 |
|---|
| 68071-3340-4 | 68071334004 | 4 TABLET in 1 BOX (68071-3340-4) | 4 tablet | 2017-07-21 | 0000-00-00 | No | No | Current |