Alendronate Sodium NDC 0054-0282

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0282Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0282Add 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
0054-0282-59	00054028259	4 BOTTLE, UNIT-DOSE in 1 CARTON (0054-0282-59) / 75 mL in 1 BOTTLE, UNIT-DOSEMarketed from Oct 30, 2020

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Alendronate Sodium
Generic name (nonproprietary): alendronate sodium
Active ingredients: Alendronate sodium — 70 mg/75mL
Dosage form: Solution
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090520
Marketing start: Oct 30, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Diphosphonates (Chemical structure)
Identifiers: Product ID 0054-0282_56e063a8-8c3d-4445-91fd-0c8806c2b127SPL ID 56e063a8-8c3d-4445-91fd-0c8806c2b127SPL set ID c910bb05-279b-4ffa-a867-46f4a0853ed5RxCUI 904447UNII 2UY4M2U3RAUPC 0300540282592
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

N400054028259 followed by a unit qualifier and the quantity

Package 00054-0282-59. 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 Jan 15, 2026.

Indications (excerpt from the label)

Alendronate Sodium Oral Solution is a bisphosphonate indicated for: • Treatment of osteoporosis in postmenopausal women ( 1.1 ) • Treatment to increase bone mass in men with osteoporosis ( 1.3 ) 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 Alendronate sodium is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures) [see Clinical Studi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)