What is NDC 16714-631?

16714-631 is the product NDC for Alendronate Sodium, Alendronate sodium 10 mg/1 tablet, listed with the FDA by NorthStar Rx LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

NorthStar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Alendronate Sodium?

27 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Alendronate Sodium NDC 16714-631 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-631Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0631Add 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
16714-631-01	1671406310116714063101	30 TABLET in 1 BOTTLE (16714-631-01)Marketed from Aug 4, 2008
16714-631-02	1671406310216714063102	100 TABLET in 1 BOTTLE (16714-631-02)Marketed from Aug 4, 2008
16714-631-11	1671406311116714063111	10 BLISTER PACK in 1 CARTON (16714-631-11) / 10 TABLET in 1 BLISTER PACK (16714-631-10)Marketed from Aug 4, 2008

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 Sodium
Generic name (nonproprietary): alendronate sodium
Active ingredients: Alendronate sodium — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: NorthStar Rx LLCNDC labeler code 16714
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090124
Marketing start: Aug 4, 2008
Listing expires: Dec 31, 2027
Other FDA classes: Diphosphonates (Chemical structure)
Identifiers: Product ID 16714-631_aed28579-c63c-48b1-8b67-e24137d0709aSPL ID aed28579-c63c-48b1-8b67-e24137d0709aSPL set ID 4323d3aa-cbb0-41e2-aba7-7a94a0516993RxCUI 904396, 904419, 904431UNII 2UY4M2U3RAUPC 0316714631011, 0316714631110
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

N416714063101 followed by a unit qualifier and the quantity

Package 16714-0631-01. 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 Jun 12, 2026.

Indications (excerpt from the label)

Alendronate sodium 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 Alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, alendronate sodium tablets increases bone mass and reduces…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16714-631

What is NDC 16714-631?: 16714-631 is the product NDC for Alendronate Sodium, Alendronate sodium 10 mg/1 tablet, listed with the FDA by NorthStar Rx LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Alendronate Sodium.
What is the active ingredient?: Alendronate sodium.
Who is the labeler?: NorthStar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Alendronate Sodium?: 27 other product NDCs are listed under this name. See all Alendronate Sodium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Alendronate Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Alendronate Sodium	Alendronate sodium 70 mg/75mL	SolutionOral	ANI Pharmaceuticals, Inc.	70954-264	70954-0264-10
Alendronate Sodium	Alendronate sodium 35 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-681	76282-0681-46
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	EXELAN PHARMACEUTICALS INC.	76282-682	76282-0682-46
Alendronate Sodium	Alendronate sodium 70 mg/75mL	SolutionOral	Hikma Pharmaceuticals USA Inc.	0054-0282	00054-0282-59
Alendronate Sodium	Alendronate sodium 35 mg/1	TabletOral	REMEDYREPACK INC.	70518-1192	70518-1192-01
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7130	68788-7130-04
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	REMEDYREPACK INC.	70518-0033	70518-0033-00
Alendronate Sodium	Alendronate sodium 35 mg/1	TabletOral	NorthStar Rx LLC	16714-632	16714-0632-0116714-0632-0216714-0632-11
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	NorthStar Rx LLC	16714-633	16714-0633-0116714-0633-0216714-0633-11
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	A-S Medication Solutions	50090-3126	50090-3126-0050090-3126-01

All 28 Alendronate Sodium NDCs

Other NDCs under ANDA 090124

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

FDA NDC Directory listings under ANDA 090124
Product	Strength	Form · route	Labeler	Product NDC
Alendronate Sodium	Alendronate sodium 35 mg/1	TabletOral	A-S Medication Solutions	50090-5474
Alendronate Sodium	Alendronate sodium 10 mg/1	TabletOral	Aurobindo Pharma Limited	65862-327
Alendronate Sodium	Alendronate sodium 35 mg/1	TabletOral	Aurobindo Pharma Limited	65862-328
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	Aurobindo Pharma Limited	65862-329
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	A-S Medication Solutions	50090-5677
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	Proficient Rx LP	71205-048
Alendronate Sodium	Alendronate sodium 35 mg/1	TabletOral	NorthStar Rx LLC	16714-632
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	NorthStar Rx LLC	16714-633
Alendronate Sodium	Alendronate sodium 10 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-340
Alendronate Sodium	Alendronate sodium 35 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-341
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	Rising Pharma Holdings, Inc.	64980-342
Alendronate Sodium	Alendronate sodium 70 mg/1	TabletOral	A-S Medication Solutions	50090-3126