Prescription drug · NDA
Actonel (Risedronate sodium) NDC 0430-0472
Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1 · Tablet, Film coated · Oral · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0430-0472-03 | 0043004720300430047203 | 4 TABLET, FILM COATED in 1 DOSE PACK (0430-0472-03)Marketed from May 17, 2002 |
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 — 30.1 mg/1Risedronate sodium monohydrate — 4.9 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Allergan, Inc.NDC labeler code 0430
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020835
- Marketing start
- Listing expires
- Other FDA classes
- Diphosphonates (Chemical structure)Diphosphonates (Chemical structure)
- Identifiers
- Product ID 0430-0472_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 F67L43UT5C, HU2YAQ274O
- 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
N400430047203followed by a unit qualifier and the quantityPackage 00430-0472-03. 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)
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.
About NDC 0430-0472
- What is NDC 0430-0472?
- 0430-0472 is the product NDC for Actonel (risedronate sodium), Risedronate sodium hemipentahydrate 30.1 mg/1; Risedronate sodium monohydrate 4.9 mg/1 tablet, film coated, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Actonel (Risedronate Sodium).
- What is the active ingredient?
- Risedronate sodium hemipentahydrate, Risedronate sodium monohydrate.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0430. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Actonel?
- 1 other product NDC are listed under this name. See all Actonel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Actonel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Actonelrisedronate sodium | Risedronate sodium hemipentahydrate 129 mg/1; Risedronate sodium monohydrate 21 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0430-0478 | 00430-0478-01 |
Other NDCs under NDA 020835
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Actonelrisedronate sodium | Risedronate sodium hemipentahydrate 129 mg/1; Risedronate sodium monohydrate 21 mg/1 | Tablet, Film coatedOral | Allergan, Inc. | 0430-0478 |
| 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 |