Alendronate Sodium
- Product NDC
- 0054-0282
- 11-digit product format
- 000540282
- Labeler code
- 0054
- Product ID
- 0054-0282_56e063a8-8c3d-4445-91fd-0c8806c2b127
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alendronate Sodium
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA090520
- Marketing category
- ANDA
- Marketing start
- 2020-10-30
- 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 |
|---|
| 0054-0282-59 | Alendronate Sodium | 75 mL in 1 BOTTLE, UNIT-DOSE | SOLUTION | 75 | | 4 |
| 0054-0282-59 | Alendronate Sodium | 4 in 1 CARTON | SOLUTION | 4 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-0282 | ALENDRONATE SODIUM SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20201030_c910bb05-279b-4ffa-a867-46f4a0853ed5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0054-0282-59 | 00054028259 | 4 BOTTLE, UNIT-DOSE in 1 CARTON (0054-0282-59) / 75 mL in 1 BOTTLE, UNIT-DOSE | 2020-10-30 | 0000-00-00 | No | No | Current |