Alendronate Sodium
- Product NDC
- 68258-3014
- 11-digit product format
- 682583014
- Labeler code
- 68258
- Product ID
- 68258-3014_8de3b358-74d1-485b-bf3d-f70a6140bf81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alendronate sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Dispensing Solutions Inc.
- Application
- ANDA076984
- Marketing category
- ANDA
- Marketing start
- 2009-03-03
- Marketing end
- 0000-00-00
- Substance
- ALENDRONATE SODIUM
- Active strength
- 70 mg/1
- Pharmacologic classes
- Bisphosphonate [EPC],Diphosphonates [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b55122e7-1795-3be6-8216-d42256d80e7d | Product name | 2 | 20250224 |
| c3d77bcb-5cf1-4ea6-9307-38d8932a8b0a | Product name | 1 | 20240513 |
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
| c00e0569-fbc4-d31d-3ec8-d316fcedaffc | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68258-3014-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-bc4f-621f-e053-dbdaa90a74ad | ALENDRONATE SODIUM TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68258-3014-1 | Alendronate Sodium | 4 in 1 BOTTLE, PLASTIC | TABLET | 4 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ACTIVE INGREDIENT | 2UY4M2U3RA | ALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| alendronic acid | ACTIVE MOIETY | X1J18R4W8P | ALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68258-3014 | ALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.] | 1 | Legacy NDC, 1 package rows | 20100224_62af73fb-c9b7-4034-9794-dbb50420e62b.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904431 | alendronate sodium 70 MG Oral Tablet | PSN | 62af73fb-c9b7-4034-9794-dbb50420e62b | 1 |
| 904431 | alendronic acid 70 MG Oral Tablet | SCD | 62af73fb-c9b7-4034-9794-dbb50420e62b | 1 |
| 904431 | alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet | SY | 62af73fb-c9b7-4034-9794-dbb50420e62b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 68258-3014-1 | 68258301401 | 4 in 1 BOTTLE, PLASTIC | Historical |