NDC codes

FDA NDC Directory
Product NDC (as listed)65862-517Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0517Add 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
65862-517-22658620517222000 TABLET, FILM COATED in 1 BOTTLE (65862-517-22)Marketed from Nov 30, 2015
65862-517-306586205173030 TABLET, FILM COATED in 1 BOTTLE (65862-517-30)Marketed from Nov 30, 2015
65862-517-786586205177810 BLISTER PACK in 1 CARTON (65862-517-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-517-10)Marketed from Nov 30, 2015

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)
Risedronate Sodium
Generic name (nonproprietary)
risedronate sodium
Active ingredients
Risedronate sodium — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200296
Marketing start
Listing expires
Other FDA classes
Diphosphonates (Chemical structure)
Identifiers
Product ID 65862-517_9488209f-f3ad-4726-be89-f6a7e59e6885SPL ID 9488209f-f3ad-4726-be89-f6a7e59e6885SPL set ID 89896dfe-f69d-4cb3-bb71-7a7c611071faRxCUI 905024, 905032, 905041, 905092, 905100UNII OFG5EXG60L
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

N465862051722 followed by a unit qualifier and the quantity

Package 65862-0517-22. 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 tablets are 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 tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, risedronate sodium tablets reduce the inciden…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200296

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

FDA NDC Directory listings under ANDA 200296
ProductStrengthForm · routeLabelerProduct NDC
Risedronate SodiumRisedronate sodium 35 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-519
Risedronate SodiumRisedronate sodium 30 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-518

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