Alendronate Sodium
- Product NDC
- 66116-428
- 11-digit product format
- 661160428
- Labeler code
- 66116
- Product ID
- 66116-428_a9942f9c-5929-4b9b-aa27-64f7f9b164e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Alendronate Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- MedVantx, Inc.
- Application
- ANDA075710
- Marketing category
- ANDA
- Marketing start
- 2008-02-06
- 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 |
|---|---|---|---|---|---|
| 66116-428-04 | 2019-11-27 | C162847 | 48780-1 | 9855d018-dfc1-cd31-e053-dbdaa90ab51a | These highlights do not include all the information needed to use Alendronate Sodium Tablets USP safely and effectively. See full prescribing information for Alendronate Sodium Tablets USP. ALENDRONATE Sodium Tablets USP for oral use Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66116-428-04 | Alendronate Sodium | 4 in 1 BOX | TABLET | 4 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ACTIVE INGREDIENT | 2UY4M2U3RA | ALENDRONATE SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| ALENDRONIC ACID | ACTIVE MOIETY | X1J18R4W8P | ALENDRONATE SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ALENDRONATE SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | ALENDRONATE SODIUM TABLET [MEDVANTX, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ALENDRONATE SODIUM TABLET [MEDVANTX, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904431 | alendronate sodium 70 MG Oral Tablet | PSN | a9942f9c-5929-4b9b-aa27-64f7f9b164e3 | 1 |
| 904431 | alendronic acid 70 MG Oral Tablet | SCD | a9942f9c-5929-4b9b-aa27-64f7f9b164e3 | 1 |
| 904431 | alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet | SY | a9942f9c-5929-4b9b-aa27-64f7f9b164e3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 66116-428-04 | 66116042804 | 4 in 1 BOX | Historical |