Zoledronic Acid
- Product NDC
- 63323-961
- 11-digit product format
- 633230961
- Labeler code
- 63323
- Product ID
- 63323-961_fd2c8ca9-52d9-4df8-bcd8-8569a4989cd0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zoledronic Acid
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA202923
- Marketing category
- ANDA
- Marketing start
- 2014-09-04
- Substance
- ZOLEDRONIC ACID
- Active strength
- 4 mg/5mL
- 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 | 4 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6XC1PAD3KF |
| Rxcui | 351114 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-961-98 | Zoledronic Acid | 1 in 1 CARTON | INJECTION | 1 | | 11 |
| 63323-961-98 | Zoledronic Acid | 5 mL in 1 VIAL | INJECTION | 5 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-961 | ZOLEDRONIC ACID INJECTION [FRESENIUS KABI USA, LLC
] | 11 | Current NDC, Legacy NDC, 2 package rows | 20230831_f3f9de47-3d85-4d0c-a29e-1635cad3a970.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 |
|---|
| 63323-961-98 | 63323096198 | 1 VIAL in 1 CARTON (63323-961-98) / 5 mL in 1 VIAL | 1 vial | 2014-09-04 | 0000-00-00 | No | No | Current |