Alendronate Sodium
- Product NDC
- 70954-264
- 11-digit product format
- 709540264
- Labeler code
- 70954
- Product ID
- 70954-264_844cce5a-3714-4394-be02-a25a6255330a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alendronate Sodium
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA214512
- Marketing category
- ANDA
- Marketing start
- 2023-05-24
- Substance
- ALENDRONATE SODIUM
- Active strength
- 70 mg/75mL
- 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 | 70 mg/75mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2UY4M2U3RA |
| Rxcui | 904447 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-264-10 | Alendronate Sodium | 75 mL in 1 BOTTLE | SOLUTION | 75 | | 2 |
| 70954-264-10 | Alendronate Sodium | 4 in 1 CARTON | SOLUTION | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-264 | ALENDRONATE SODIUM SOLUTION [ANI PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20230525_81589178-10c9-4806-91eb-54e638d35b8d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70954-264-10 | 70954026410 | 4 BOTTLE in 1 CARTON (70954-264-10) / 75 mL in 1 BOTTLE | 4 bottle | 2023-05-24 | No | No | Current |