Zoledronic acid
- Product NDC
- 16729-242
- 11-digit product format
- 167290242
- Labeler code
- 16729
- Product ID
- 16729-242_40aa7571-f6b0-3f64-e063-6394a90ae2c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zoledronic acid
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA205279
- Marketing category
- ANDA
- Marketing start
- 2017-10-16
- 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 |
|---|
| 16729-242-31 | Zoledronic acid | 1 in 1 CARTON | INJECTION | 1 | | 7 |
| 16729-242-31 | Zoledronic acid | 5 mL in 1 VIAL | INJECTION | 5 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-242 | ZOLEDRONIC ACID INJECTION [ACCORD HEALTHCARE INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241004_3df715a1-2562-4374-a383-6edc33c6e52f.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 |
|---|
| 16729-242-31 | 16729024231 | 1 VIAL in 1 CARTON (16729-242-31) / 5 mL in 1 VIAL | 1 vial | 2017-10-16 | 0000-00-00 | No | No | Current |