Ibandronate Sodium
- Product NDC
- 60505-6097
- 11-digit product format
- 605056097
- Labeler code
- 60505
- Product ID
- 60505-6097_63d90e35-b379-2511-e5fd-b75c1d1d5dde
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ibandronate sodium
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Apotex Corp.
- Application
- ANDA204222
- Marketing category
- ANDA
- Marketing start
- 2016-01-13
- Substance
- IBANDRONATE SODIUM
- Active strength
- 3 mg/3mL
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibandronate Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBANDRONATE SODIUM | 3 mg/3mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | J12U072QL0 |
| Rxcui | 904952 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60505-6097-0 | Ibandronate Sodium | 3 mL in 1 SYRINGE, GLASS | INJECTION | 3 | | 10 |
| 60505-6097-0 | Ibandronate Sodium | 1 in 1 CARTON | INJECTION | 1 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-6097 | IBANDRONATE SODIUM INJECTION [APOTEX CORP.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241004_9fad4982-95af-d711-f50a-867311835143.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-6097-0 | 60505609700 | 1 SYRINGE, GLASS in 1 CARTON (60505-6097-0) / 3 mL in 1 SYRINGE, GLASS | 2016-01-13 | 0000-00-00 | No | No | Current |