FOSAMAX
- Product NDC
- 78206-135
- 11-digit product format
- 782060135
- Labeler code
- 78206
- Product ID
- 78206-135_1013aa0b-071e-46c4-8bed-207bb10ac2fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alendronate sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Organon LLC
- Application
- NDA020560
- Marketing category
- NDA
- Marketing start
- 2021-06-01
- Substance
- ALENDRONATE SODIUM
- Active strength
- 70 mg/1
- 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
- FOSAMAX
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALENDRONATE SODIUM | 70 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2UY4M2U3RA |
| Rxcui | 904431, 904433 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 78206-135-01 | FOSAMAX | 4 in 1 BLISTER PACK | TABLET | 4 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78206-135 | FOSAMAX (ALENDRONATE SODIUM) TABLET [ORGANON LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240418_14e931fd-2c5f-4d90-b7db-5980706f4a56.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 78206-135-01 | 78206013501 | 4 TABLET in 1 BLISTER PACK (78206-135-01) | 4 tablet | 2021-06-01 | 0000-00-00 | No | No | Current |