Ibandronate Sodium
- Product NDC
- 55150-191
- 11-digit product format
- 551500191
- Labeler code
- 55150
- Product ID
- 55150-191_9e93dc68-5558-4271-9f1f-44f4313babae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ibandronate Sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA205332
- Marketing category
- ANDA
- Marketing start
- 2015-08-19
- 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 |
|---|
| 55150-191-83 | Ibandronate Sodium | 3 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 3 | | 11 |
| 55150-191-83 | Ibandronate Sodium | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-191 | IBANDRONATE SODIUM INJECTION, SOLUTION [EUGIA US LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240922_e81f2c5b-bead-48ac-be3e-016cf963d7ed.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 |
|---|
| 55150-191-83 | 55150019183 | 1 SYRINGE, GLASS in 1 CARTON (55150-191-83) / 3 mL in 1 SYRINGE, GLASS | 2015-08-19 | 0000-00-00 | No | No | Current |