Zoledronic Acid
- Product NDC
- 67457-794
- 11-digit product format
- 674570794
- Labeler code
- 67457
- Product ID
- 67457-794_b6b103d8-2eaa-4de8-a501-547f977cffd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zoledronic Acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA205254
- Marketing category
- ANDA
- Marketing start
- 2018-06-05
- Substance
- ZOLEDRONIC ACID
- Active strength
- 5 mg/100mL
- 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
- Zoledronic Acid
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLEDRONIC ACID | 5 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6XC1PAD3KF |
| Rxcui | 705824 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67457-794-10 | Zoledronic Acid | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 5 |
| 67457-794-10 | Zoledronic Acid | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-794 | ZOLEDRONIC ACID INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230120_80006f10-85a3-4390-b5dc-3b2097134f3d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-794-10 | 67457079410 | 1 BAG in 1 POUCH (67457-794-10) / 100 mL in 1 BAG | 1 bag | 2018-06-05 | 0000-00-00 | No | No | Current |