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NDC 60505-3165-00 Risedronate Sodium 35 mg/1 Details
Risedronate Sodium 35 mg/1
Risedronate Sodium is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is RISEDRONATE SODIUM.
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: 60505-3165-00Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Risedronate
Product Information
| NDC | 60505-3165 |
|---|---|
| Product ID | 60505-3165_03428ba0-f6f3-be31-dc50-def19fdd4184 |
| Associated GPIs | 30042065100330 |
| GCN Sequence Number | 050364 |
| GCN Sequence Number Description | risedronate sodium TABLET 35 MG ORAL |
| HIC3 | P4L |
| HIC3 Description | BONE RESORPTION INHIBITORS |
| GCN | 17378 |
| HICL Sequence Number | 018565 |
| HICL Sequence Number Description | RISEDRONATE SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Risedronate Sodium |
| 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 | 35 |
| Active Ingredient Units | mg/1 |
| Substance Name | RISEDRONATE SODIUM |
| Labeler Name | Apotex Corp. |
| Pharmaceutical Class | Bisphosphonate [EPC], Diphosphonates [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090877 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 60505-3165-00 (60505316500)
| NDC Package Code | 60505-3165-0 |
|---|---|
| Billing NDC | 60505316500 |
| Package | 1 BLISTER PACK in 1 CARTON (60505-3165-0) / 4 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2015-11-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 2.5507 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | RISEDRONATE SODIUM 35 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |