Prescription drug · NDA
Fosamax Plus D NDC 78206-136
alendronate sodium and cholecalciferol · Alendronate sodium 70 mg/1; Cholecalciferol 5600 [iU]/1 · Tablet · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-136-01 | 78206013601 | 4 TABLET in 1 BLISTER PACK (78206-136-01)Marketed from Jun 1, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Fosamax Plus D
- Generic name (nonproprietary)
- alendronate sodium and cholecalciferol
- Active ingredients
- Alendronate sodium — 70 mg/1Cholecalciferol — 5600 [iU]/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Organon LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021762
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)Vitamin D (Chemical structure)
- Identifiers
- Product ID 78206-136_10aeb309-f6e1-49c6-ac6f-ad743db28527SPL ID 10aeb309-f6e1-49c6-ac6f-ad743db28527SPL set ID 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1RxCUI 904462, 904465, 904492, 904495UNII 1C6V77QF41, 2UY4M2U3RA
- Pharmacologic class
- Bisphosphonate; Vitamin D
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N478206013601followed by a unit qualifier and the quantityPackage 78206-0136-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
FOSAMAX PLUS D is a combination of a bisphosphonate and vitamin D indicated for: Treatment of osteoporosis in postmenopausal women ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Limitations of use : FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. ( 1.3 ) Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. ( 1.3 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women FOSAMAX ® PLUS D is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX PLUS D increases bone mass and reduces the incidence of fractures, …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021762
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fosamax Plus Dalendronate sodium and cholecalciferol | Alendronate sodium 70 mg/1; Cholecalciferol 2800 [iU]/1 | TabletOral | Organon LLC | 78206-137 |