Actonel (risedronate sodium) NDC 0430-0478

NDC codes

FDA NDC Directory

Product NDC (as listed)0430-0478Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00430-0478Add 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	Copy
0430-0478-01	00430047801	1 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-01)Marketed from Apr 22, 2008

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): Actonel
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
Labeler: Allergan, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020835
Marketing start: Apr 22, 2008
Listing expires: Dec 31, 2027
Other FDA classes: Diphosphonates (Chemical structure)Diphosphonates (Chemical structure)
Identifiers: Product ID 0430-0478_a874a4b5-3deb-40b1-9cb8-d80c3fca4401SPL ID a874a4b5-3deb-40b1-9cb8-d80c3fca4401SPL set ID 24ed00e0-25e2-49a8-97fc-66c1b417dc0bRxCUI 905024, 905026, 905028, 905030, 905032, 905034, 905041, 905043, 905083, 905084, 905086, 905087, 905092, 905093, 905100, 905101UNII 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

N400430047801 followed by a unit qualifier and the quantity

Package 00430-0478-01. 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 Feb 4, 2026.

Indications (excerpt from the label)

ACTONEL 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 ACTONEL is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ACTONEL reduces the incidence of vertebral fractures and a composite endpoint…

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
Product	Strength	Form · route	Labeler	Product NDC
Actonelrisedronate sodium	Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1	Tablet, Film coatedOral	Allergan, Inc.	0430-0472
Risedronate Sodium	Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals, Inc.	59762-0405
Risedronate Sodium	Risedronate sodium hemipentahydrate 129 mg/1; Risedronate sodium monohydrate 21 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals, Inc.	59762-0406