Fosamax (alendronate sodium) NDC 78206-135

NDC codes

FDA NDC Directory

Product NDC (as listed)78206-135Labeler and product segments. Claims need a package NDC.

Product NDC at billing width78206-0135Add 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 NDC	11-digit (billing)	Package	Copy
78206-135-01	78206013501	4 TABLET in 1 BLISTER PACK (78206-135-01)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
Generic name (nonproprietary): alendronate sodium
Active ingredients: Alendronate sodium — 70 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Organon LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020560
Marketing start: Jun 1, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Diphosphonates (Chemical structure)
Identifiers: Product ID 78206-135_1013aa0b-071e-46c4-8bed-207bb10ac2fdSPL ID 1013aa0b-071e-46c4-8bed-207bb10ac2fdSPL set ID 14e931fd-2c5f-4d90-b7db-5980706f4a56RxCUI 904431, 904433UNII 2UY4M2U3RA
Pharmacologic class: Bisphosphonate

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

N478206013501 followed by a unit qualifier and the quantity

Package 78206-0135-01. 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 Mar 12, 2026.

Indications (excerpt from the label)

FOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1 , 1.2 ) Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Treatment of glucocorticoid-induced osteoporosis ( 1.4 ) Treatment of Paget's disease of bone ( 1.5 ) Limitations of use : 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. ( 1.6 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women FOSAMAX ® is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, FOSAMAX increases bone mass and reduces the incidence of fractures, includin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)