Alendronate Sodium
- Product NDC
- 21695-901
- 11-digit product format
- 216950901
- Labeler code
- 21695
- Product ID
- 21695-901_eb668bf3-aab0-4529-bf8f-e740a5d5f3b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alendronate sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA076768
- Marketing category
- ANDA
- Marketing start
- 2008-08-04
- Marketing end
- 0000-00-00
- Substance
- ALENDRONATE SODIUM
- Active strength
- 35 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 |
|---|---|---|---|---|---|
| 21695-901-04 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4d49-48b1-e053-8cdaa90a720a | ALENDRONATE SODIUM TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-901-04 | Alendronate Sodium | 4 in 1 BLISTER PACK | TABLET | 4 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-901-04 | EA - Each | 21695-901 | b433caff-98ae-4591-9589-89f94daf3de4 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| alendronate sodium | ACTIVE INGREDIENT | 2UY4M2U3RA | ALENDRONATE SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| alendronic acid | ACTIVE MOIETY | X1J18R4W8P | ALENDRONATE SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ALENDRONATE SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ALENDRONATE SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ALENDRONATE SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ALENDRONATE SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | ALENDRONATE SODIUM TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904396 | alendronate sodium 35 MG Oral Tablet | PSN | eb668bf3-aab0-4529-bf8f-e740a5d5f3b8 | 1 |
| 904431 | alendronate sodium 70 MG Oral Tablet | PSN | eb668bf3-aab0-4529-bf8f-e740a5d5f3b8 | 1 |
| 904396 | alendronic acid 35 MG Oral Tablet | SCD | eb668bf3-aab0-4529-bf8f-e740a5d5f3b8 | 1 |
| 904431 | alendronic acid 70 MG Oral Tablet | SCD | eb668bf3-aab0-4529-bf8f-e740a5d5f3b8 | 1 |
| 904396 | alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral Tablet | SY | eb668bf3-aab0-4529-bf8f-e740a5d5f3b8 | 1 |
| 904431 | alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet | SY | eb668bf3-aab0-4529-bf8f-e740a5d5f3b8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 21695-901-04 | 21695090104 | 4 in 1 BLISTER PACK | Historical |