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NDC 00430-0478-02 Actonel 129; 21 mg/1; mg/1 Details
Actonel 129; 21 mg/1; mg/1
Actonel is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Allergan, Inc.. The primary component is RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE.
MedlinePlus Drug Summary
Risedronate tablets and delayed-release (long-acting tablets) are used to prevent and treat osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause (''change of life,'' end of menstrual periods). Risedronate tablets are also used to treat osteoporosis in men, and in men and women who are taking glucocorticoids (a type of corticosteroid medication that may cause osteoporosis). Risedronate tablets are also used to treat Paget's disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Risedronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).
Related Packages: 00430-0478-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Risedronate
Product Information
| NDC | 00430-0478 |
|---|---|
| Product ID | 0430-0478_7d8b4cf5-8395-4a5e-8def-feaaf742fb21 |
| Associated GPIs | 30042065100380 |
| GCN Sequence Number | 063925 |
| GCN Sequence Number Description | risedronate sodium TABLET 150 MG ORAL |
| HIC3 | P4L |
| HIC3 Description | BONE RESORPTION INHIBITORS |
| GCN | 99637 |
| HICL Sequence Number | 018565 |
| HICL Sequence Number Description | RISEDRONATE SODIUM |
| Brand/Generic | Brand |
| Proprietary Name | Actonel |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Risedronate Sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 129; 21 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE |
| Labeler Name | Allergan, Inc. |
| Pharmaceutical Class | Bisphosphonate [EPC], Bisphosphonate [EPC], Diphosphonates [CS], Diphosphonates [CS] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020835 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00430-0478-02 (00430047802)
| NDC Package Code | 0430-0478-02 |
|---|---|
| Billing NDC | 00430047802 |
| Package | 3 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-02) |
| Marketing Start Date | 2008-04-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |