Alendronate Sodium
- Product NDC
- 16714-632
- 11-digit product format
- 167140632
- Labeler code
- 16714
- Product ID
- 16714-632_7e91c532-463d-4abd-96e9-08f5207db1c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alendronate Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA090124
- Marketing category
- ANDA
- Marketing start
- 2008-08-04
- Substance
- ALENDRONATE SODIUM
- Active strength
- 35 mg/1
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | 35 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2UY4M2U3RA |
| Rxcui | 904396, 904419, 904431 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-632-01 | Alendronate Sodium | 4 in 1 BLISTER PACK | TABLET | 4 | | 16 |
| 16714-632-01 | Alendronate Sodium | 1 in 1 CARTON | TABLET | 1 | | 16 |
| 16714-632-02 | Alendronate Sodium | 5 in 1 CARTON | TABLET | 5 | | 16 |
| 16714-632-02 | Alendronate Sodium | 4 in 1 BLISTER PACK | TABLET | 4 | | 16 |
| 16714-632-10 | Alendronate Sodium | 10 in 1 BLISTER PACK | TABLET | 10 | | 16 |
| 16714-632-11 | Alendronate Sodium | 10 in 1 CARTON | TABLET | 10 | | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-632 | ALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC] | 15 | Current NDC, Legacy NDC, 6 package rows | 20240426_4323d3aa-cbb0-41e2-aba7-7a94a0516993.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 |
|---|
| 16714-632-01 | 16714063201 | 1 BLISTER PACK in 1 CARTON (16714-632-01) / 4 TABLET in 1 BLISTER PACK | 1 blister pack | 2008-08-04 | 0000-00-00 | No | No | Current |
| 16714-632-02 | 16714063202 | 5 BLISTER PACK in 1 CARTON (16714-632-02) / 4 TABLET in 1 BLISTER PACK | 5 blister pack | 2008-08-04 | 0000-00-00 | No | No | Current |
| 16714-632-10 | 16714063210 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 16714-632-11 | 16714063211 | 10 BLISTER PACK in 1 CARTON (16714-632-11) / 10 TABLET in 1 BLISTER PACK (16714-632-10) | 10 blister pack | 2008-08-04 | 0000-00-00 | No | No | Current |