alendronate sodium
- Product NDC
- 50090-1091
- 11-digit product format
- 500901091
- Labeler code
- 50090
- Product ID
- 50090-1091_2ebcc844-dc8c-43cc-83e2-09254cfb47e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alendronate sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA076984
- Marketing category
- ANDA
- Marketing start
- 2009-10-23
- Marketing end
- 0000-00-00
- Substance
- ALENDRONATE SODIUM
- Active strength
- 35 mg/1
- Pharmacologic classes
- Bisphosphonate [EPC],Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|---|---|---|---|---|
| 50090-1091-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-62a1-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-1091-0 | alendronate sodium | 4 in 1 BLISTER PACK | TABLET | 4 | 8 | |
| 50090-1091-0 | alendronate sodium | 1 in 1 BOX, UNIT-DOSE | TABLET | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-1091-0 | EA - Each | 50090-1091 | e6c61c1f-c906-421a-a622-c56894e427c2 | 1 | 2018-11-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-1091 | ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS] | 8 | Legacy NDC, 2 package rows | 20180828_532987e4-cfe5-4902-9ea9-6555b101548c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904396 | alendronate sodium 35 MG Oral Tablet | PSN | 532987e4-cfe5-4902-9ea9-6555b101548c | 8 |
| 904431 | alendronate sodium 70 MG Oral Tablet | PSN | 532987e4-cfe5-4902-9ea9-6555b101548c | 8 |
| 904396 | alendronic acid 35 MG Oral Tablet | SCD | 532987e4-cfe5-4902-9ea9-6555b101548c | 8 |
| 904431 | alendronic acid 70 MG Oral Tablet | SCD | 532987e4-cfe5-4902-9ea9-6555b101548c | 8 |
| 904396 | alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral Tablet | SY | 532987e4-cfe5-4902-9ea9-6555b101548c | 8 |
| 904431 | alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet | SY | 532987e4-cfe5-4902-9ea9-6555b101548c | 8 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50090-1091-0 | 50090109100 | 4 in 1 BLISTER PACK | Historical |