NDC codes

FDA NDC Directory
Product NDC (as listed)78206-137Labeler and product segments. Claims need a package NDC.
Product NDC at billing width78206-0137Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
78206-137-01782060137014 TABLET in 1 BLISTER PACK (78206-137-01)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 — 2800 [iU]/1
Dosage form
Tablet
Route
Oral
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 78206-137_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

N478206013701 followed by a unit qualifier and the quantity

Package 78206-0137-01. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021762

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021762
ProductStrengthForm · routeLabelerProduct NDC
Fosamax Plus Dalendronate sodium and cholecalciferolAlendronate sodium 70 mg/1; Cholecalciferol 5600 [iU]/1TabletOralOrganon LLC78206-136

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