NDC codes

FDA NDC Directory
Product NDC (as listed)70539-400Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70539-0400Add 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 NDC11-digit (billing)PackageCopy
70539-400-0470539040004705390400044 BLISTER PACK in 1 BOX (70539-400-04) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)Marketed from Mar 12, 2012
70539-400-9470539040094705390400944 BLISTER PACK in 1 BOX (70539-400-94) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)Marketed from Mar 12, 2023

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)
Binosto
Generic name (nonproprietary)
alendronate sodium
Active ingredients
Alendronate sodium — 91.37 mg/1
Dosage form
Tablet, Effervescent
Route
Oral
Labeler
Radius Health, Inc.NDC labeler code 70539
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 202344
Marketing start
Listing expires
Other FDA classes
Diphosphonates (Chemical structure)
Identifiers
Product ID 70539-400_1ff6288a-ab6b-4443-81bd-fd1a37a2bd16SPL ID 1ff6288a-ab6b-4443-81bd-fd1a37a2bd16SPL set ID 09765234-01bc-40f7-b9bb-c167056f3909RxCUI 1248077, 1248083UNII 2UY4M2U3RAUPC 0370539400009
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

N470539040004 followed by a unit qualifier and the quantity

Package 70539-0400-04. 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 .

Indications (excerpt from the label)

BINOSTO is a bisphosphonate indicated for: Treatment of osteoporosis in postmenopausal women ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Limitation 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 ( 1.3 ) 1.1 Treatment of Osteoporosis in Postmenopausal Women BINOSTO effervescent tablet 70 mg is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, alendronate sodium increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [See Clinical Stu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70539-400

What is NDC 70539-400?
70539-400 is the product NDC for Binosto (alendronate sodium), Alendronate sodium 91.37 mg/1 tablet, effervescent, listed with the FDA by Radius Health, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Binosto (Alendronate sodium).
What is the active ingredient?
Alendronate sodium.
Who is the labeler?
Radius Health, Inc., NDC labeler code 70539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Binosto?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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