NDC codes

FDA NDC Directory
Product NDC (as listed)0430-0979Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00430-0979Add 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
0430-0979-03004300979034 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)Marketed from Dec 1, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Atelvia
Generic name (nonproprietary)
risedronate sodium
Active ingredients
Risedronate sodium hemipentahydrate — 30.1 mg/1Risedronate sodium monohydrate — 4.9 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022560
Marketing start
Listing expires
Other FDA classes
Diphosphonates (Chemical structure)Diphosphonates (Chemical structure)
Identifiers
Product ID 0430-0979_936662af-4e07-4361-b7ef-760ebfad3e01SPL ID 936662af-4e07-4361-b7ef-760ebfad3e01SPL set ID c8b9ab88-1a26-46c3-80ec-4eaa45202021RxCUI 1020064, 1020065, 1020066UNII 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

N400430097903 followed by a unit qualifier and the quantity

Package 00430-0979-03. 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)

Atelvia is a bisphosphonate in a delayed-release formulation and is indicated for treatment of postmenopausal osteoporosis ( 1.1 ) 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 ( 1.2 ) 1.1 Postmenopausal Osteoporosis Atelvia is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, risedronate sodium has been shown to reduce the incidence of vertebral fractures and a composite endpoint of nonvertebral osteoporosis-related fractures [ see Clinical Studies (14.1) ] . 1.2 Important Limitations of Use The optimal duration of use has not been …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022560

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

FDA NDC Directory listings under NDA 022560
ProductStrengthForm · routeLabelerProduct NDC
Risedronate SodiumRisedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1Tablet, Delayed releaseOralMylan Pharmaceuticals, Inc.59762-0407

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