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NDC 60505-6097-00 Ibandronate Sodium 3 mg/3mL Details
Ibandronate Sodium 3 mg/3mL
Ibandronate Sodium is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Apotex Corp.. The primary component is IBANDRONATE SODIUM.
MedlinePlus Drug Summary
Ibandronate injection is used to 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). Ibandronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).
Related Packages: 60505-6097-00Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ibandronate Injection
Product Information
| NDC | 60505-6097 |
|---|---|
| Product ID | 60505-6097_75ca1077-00cc-4742-debb-8340ceb3fb4f |
| Associated GPIs | 30042048102030 |
| GCN Sequence Number | 060257 |
| GCN Sequence Number Description | ibandronate sodium SYRINGE 3 MG/3 ML INTRAVEN |
| HIC3 | P4L |
| HIC3 Description | BONE RESORPTION INHIBITORS |
| GCN | 26368 |
| HICL Sequence Number | 017291 |
| HICL Sequence Number Description | IBANDRONATE SODIUM |
| Brand/Generic | Generic |
| Proprietary Name | Ibandronate Sodium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ibandronate sodium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 3 |
| Active Ingredient Units | mg/3mL |
| Substance Name | IBANDRONATE SODIUM |
| Labeler Name | Apotex Corp. |
| Pharmaceutical Class | Bisphosphonate [EPC], Diphosphonates [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204222 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 60505-6097-00 (60505609700)
| NDC Package Code | 60505-6097-0 |
|---|---|
| Billing NDC | 60505609700 |
| Package | 1 SYRINGE, GLASS in 1 CARTON (60505-6097-0) / 3 mL in 1 SYRINGE, GLASS |
| Marketing Start Date | 2016-01-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |