Zoledronic Acid
- Product NDC
- 83634-801
- 11-digit product format
- 836340801
- Labeler code
- 83634
- Product ID
- 83634-801_1063bd7e-52b7-4df2-bd99-64929854a7d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zoledronic acid
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Avenacy Inc.
- Application
- ANDA201783
- Marketing category
- ANDA
- Marketing start
- 2025-01-15
- 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 |
|---|
| 83634-801-05 | Zoledronic Acid | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 5 | | 1 |
| 83634-801-05 | Zoledronic Acid | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83634-801 | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [AVENACY INC.] | 1 | Current NDC, 2 package rows | 20250115_4b699dd8-d232-4bdb-88ce-9b42ed93e036.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83634-801-05 | 83634080105 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-801-05) / 5 mL in 1 VIAL, SINGLE-DOSE | 2025-01-15 | No | No | Current |