Alendronate Sodium NDC 0115-1678

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-1678Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-1678Add 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
0115-1678-01	00115167801	100 TABLET in 1 BOTTLE (0115-1678-01)Marketed from Feb 6, 2008
0115-1678-08	00115167808	30 TABLET in 1 BOTTLE (0115-1678-08)Marketed from Feb 6, 2008

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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075710
Marketing start: Feb 6, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Diphosphonates (Chemical structure)
Identifiers: Product ID 0115-1678_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1SPL ID 0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1SPL set ID c23fb7fe-c6b9-4f77-bde7-992222b589d3RxCUI 904396, 904405, 904419, 904425, 904431UNII 2UY4M2U3RAUPC 0301151681347, 0301151679344, 0301151676084, 0301151678088, 0301151680081
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

N400115167801 followed by a unit qualifier and the quantity

Package 00115-1678-01. 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 Feb 2, 2021.

Indications (excerpt from the label)

Alendronate sodium tablets are 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 Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets increase bon…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075710

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

FDA NDC Directory listings under ANDA 075710
Product	Strength	Form · route	Labeler	Product NDC
Alendronate Sodium	Alendronate sodium 5 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	0115-1676
Alendronate Sodium	Alendronate sodium 35 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	0115-1679
Alendronate Sodium	Alendronate sodium 40 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	0115-1680
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	0115-1681