Zoledronic acid
- Product NDC
- 72603-198
- 11-digit product format
- 726030198
- Labeler code
- 72603
- Product ID
- 72603-198_5499e3f9-5d5d-4eeb-a859-62cc967d468f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zoledronic acid
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- NORTHSTAR RX LLC
- Application
- ANDA201783
- Marketing category
- ANDA
- Marketing start
- 2023-11-01
- 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 |
|---|
| 72603-198-01 | Zoledronic acid | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 1 |
| 72603-198-01 | Zoledronic acid | 5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION, CONCENTRATE | 5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-198 | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [NORTHSTAR RX LLC] | 1 | Current NDC, 2 package rows | 20231101_3885488c-6b83-421b-afee-61abceb95634.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-198-01 | 72603019801 | 1 VIAL, GLASS in 1 CARTON (72603-198-01) / 5 mL in 1 VIAL, GLASS | 2023-11-01 | No | No | Current |