NDC codes

FDA NDC Directory
Product NDC (as listed)59762-0406Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59762-0406Add 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
59762-0406-1597620406011 TABLET, FILM COATED in 1 DOSE PACK (59762-0406-1)Marketed from Apr 22, 2008

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Risedronate Sodium
Generic name (nonproprietary)
risedronate sodium
Active ingredients
Risedronate sodium hemipentahydrate — 129 mg/1Risedronate sodium monohydrate — 21 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 020835
Marketing start
Listing expires
Other FDA classes
Diphosphonates (Chemical structure)Diphosphonates (Chemical structure)
Identifiers
Product ID 59762-0406_6015697f-84b2-49c4-b59a-87956261df64SPL ID 6015697f-84b2-49c4-b59a-87956261df64SPL set ID f715718a-407d-4e2a-9834-74a8f1361d03RxCUI 905024, 905028, 905092, 905100UNII HU2YAQ274O, F67L43UT5C
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

N459762040601 followed by a unit qualifier and the quantity

Package 59762-0406-01. 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 .

Indications (excerpt from the label)

Risedronate Sodium is a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) Treatment of Paget’s disease ( 1.4 ) 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. ( 1.5 ) 1.1 Postmenopausal Osteoporosis Risedronate Sodium is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Risedronate Sodium reduces the incidence of vertebral f…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 020835

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

FDA NDC Directory listings under NDA 020835
ProductStrengthForm · routeLabelerProduct NDC
Actonelrisedronate sodiumRisedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1Tablet, Film coatedOralAllergan, Inc.0430-0472
Actonelrisedronate sodiumRisedronate sodium hemipentahydrate 129 mg/1; Risedronate sodium monohydrate 21 mg/1Tablet, Film coatedOralAllergan, Inc.0430-0478
Risedronate SodiumRisedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1Tablet, Film coatedOralMylan Pharmaceuticals, Inc.59762-0405

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