Zoledronic Acid
- Product NDC
- 63323-966
- 11-digit product format
- 633230966
- Labeler code
- 63323
- Product ID
- 63323-966_9fb5ae91-44b4-4b48-aaeb-0a2ba676aa16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zoledronic Acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA204217
- Marketing category
- ANDA
- Marketing start
- 2017-02-17
- Substance
- ZOLEDRONIC ACID
- Active strength
- 5 mg/100mL
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zoledronic Acid
- Listing expiration
- 2026-12-31
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 |
|---|
| 63323-966-00 | Zoledronic Acid | 100 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 100 | | 5 |
| 63323-966-00 | Zoledronic Acid | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-966 | ZOLEDRONIC ACID INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231007_16fcf8c9-ef8a-4e93-9ee6-acfadd35a861.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 |
|---|
| 63323-966-00 | 63323096600 | 1 VIAL, GLASS in 1 CARTON (63323-966-00) / 100 mL in 1 VIAL, GLASS | 2017-02-17 | 0000-00-00 | No | No | Current |