Zoledronic acid
- Product NDC
- 68001-437
- 11-digit product format
- 680010437
- Labeler code
- 68001
- Product ID
- 68001-437_0179cc91-4a11-1cc0-e063-6294a90a6c1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zoledronic acid
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- BluePoint Laboratories
- Application
- ANDA205279
- Marketing category
- ANDA
- Marketing start
- 2020-06-29
- 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 |
|---|
| 68001-437-25 | Zoledronic acid | 1 in 1 CARTON | INJECTION | 1 | | 2 |
| 68001-437-25 | Zoledronic acid | 5 mL in 1 VIAL | INJECTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-437 | ZOLEDRONIC ACID INJECTION [BLUEPOINT LABORATORIES] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230728_666b1833-ee9b-4a6f-bd4c-9526552cec0a.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 |
|---|
| 68001-437-25 | 68001043725 | 1 VIAL in 1 CARTON (68001-437-25) / 5 mL in 1 VIAL | 1 vial | 2020-06-29 | 0000-00-00 | No | No | Current |