FOSAMAX PLUS D
- Product NDC
- 78206-136
- 11-digit product format
- 782060136
- Labeler code
- 78206
- Product ID
- 78206-136_10aeb309-f6e1-49c6-ac6f-ad743db28527
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ALENDRONATE SODIUM and CHOLECALCIFEROL
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Organon LLC
- Application
- NDA021762
- Marketing category
- NDA
- Marketing start
- 2021-06-01
- Substance
- ALENDRONATE SODIUM; CHOLECALCIFEROL
- Active strength
- 70; 5600 mg/1; [iU]/1
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS], Vitamin D [CS], Vitamin D [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FOSAMAX PLUS D
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ALENDRONATE SODIUM | 70 mg/1 |
| CHOLECALCIFEROL | 5600 [iU]/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 2UY4M2U3RA, 1C6V77QF41 |
| Rxcui | 904462, 904465, 904492, 904495 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78206-136-01 | FOSAMAX PLUS D | 4 in 1 BLISTER PACK | TABLET | 4 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 78206-136-01 | EA - Each | 78206-136 | f770244d-b705-4465-8a7a-9b8676d16b9d | 1 | 2021-08-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 904492 | alendronate sodium 70 MG / cholecalciferol 2800 UNT Oral Tablet | PSN | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904462 | alendronate sodium 70 MG / cholecalciferol 5600 UNT Oral Tablet | PSN | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904495 | FOSAMAX PLUS D 70 MG / 2800 UNT Oral Tablet | PSN | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904465 | FOSAMAX PLUS D 70 MG / 5600 UNT Oral Tablet | PSN | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904495 | alendronic acid 70 MG / cholecalciferol 2800 UNT Oral Tablet [Fosamax Plus D] | SBD | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904465 | alendronic acid 70 MG / cholecalciferol 5600 UNT Oral Tablet [Fosamax Plus D] | SBD | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904492 | alendronic acid 70 MG / cholecalciferol 2800 UNT Oral Tablet | SCD | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904462 | alendronic acid 70 MG / cholecalciferol 5600 UNT Oral Tablet | SCD | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904492 | alendronic acid 70 MG (as alendronate sodium 91.4 MG) / cholecalciferol 2800 UNT Oral Tablet | SY | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904462 | alendronic acid 70 MG (as alendronate sodium 91.4 MG) / cholecalciferol 5600 UNT Oral Tablet | SY | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904492 | alendronic acid 70 MG / vitamin D3 2800 UNT Oral Tablet | SY | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904462 | alendronic acid 70 MG / vitamin D3 5,600 UNT Oral Tablet | SY | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904495 | Fosamax Plus D 70/2800 (alendronic acid / vitamin D3) Oral Tablet | SY | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904495 | Fosamax Plus D 70/2800 Oral Tablet | SY | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904465 | Fosamax Plus D 70/5600 (alendronic acid / vitamin D3) Oral Tablet | SY | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
| 904465 | Fosamax Plus D 70/5600 Oral Tablet | SY | 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 78206-136-01 | 78206013601 | 4 TABLET in 1 BLISTER PACK (78206-136-01) | 4 tablet | 2021-06-01 | 0000-00-00 | No | No | Current |