Alendronate (alendronate sodium tablet) NDC 10135-718

NDC codes

FDA NDC Directory

Product NDC (as listed)10135-718Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10135-0718Add 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
10135-718-12	10135071812	3 BLISTER PACK in 1 CARTON (10135-718-12) / 4 TABLET in 1 BLISTER PACKMarketed from Dec 1, 2020
10135-718-44	10135071844	1 BLISTER PACK in 1 CARTON (10135-718-44) / 4 TABLET in 1 BLISTER PACKMarketed from Dec 1, 2020

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): Alendronate
Generic name (nonproprietary): alendronate sodium tablet
Active ingredients: Alendronate sodium — 35 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Marlex Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090258
Marketing start: Dec 1, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Diphosphonates (Chemical structure)
Identifiers: Product ID 10135-718_3e74abef-2742-2bbe-e063-6394a90a12cdSPL ID 3e74abef-2742-2bbe-e063-6394a90a12cdSPL set ID b63421af-ec03-1de7-e053-2a95a90abec6RxCUI 904396, 904431UNII 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

N410135071812 followed by a unit qualifier and the quantity

Package 10135-0718-12. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 090258

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

FDA NDC Directory listings under ANDA 090258
Product	Strength	Form · route	Labeler	Product NDC
Alendronatealendronate sodium tablet	Alendronate sodium 70 mg/1	TabletOral	Marlex Pharmaceuticals, Inc.	10135-719
Alendronatealendronate sodium	Alendronate sodium 35 mg/1	TabletOral	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	60723-207
Alendronatealendronate sodium	Alendronate sodium 70 mg/1	TabletOral	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	60723-205