Zoledronic Acid
- Product NDC
- 68083-142
- 11-digit product format
- 680830142
- Labeler code
- 68083
- Product ID
- 68083-142_a1d17413-5a66-4bc0-8369-c91d360bc2a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zoledronic Acid
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA205749
- Marketing category
- ANDA
- Marketing start
- 2018-07-05
- Substance
- ZOLEDRONIC ACID
- Active strength
- 4 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 | 4 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6XC1PAD3KF |
| Rxcui | 1114085 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-142-01 | Zoledronic Acid | 1 in 1 CARTON | INJECTION | 1 | | 6 |
| 68083-142-01 | Zoledronic Acid | 100 mL in 1 VIAL | INJECTION | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-142 | ZOLEDRONIC ACID INJECTION [GLAND PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20190403_1740d7d8-a101-4688-8d8b-beb00559d602.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 |
|---|
| 68083-142-01 | 68083014201 | 1 VIAL in 1 CARTON (68083-142-01) / 100 mL in 1 VIAL | 1 vial | 2018-07-05 | 0000-00-00 | No | No | Current |