Zoledronic Acid
- Product NDC
- 0143-9642
- 11-digit product format
- 001439642
- Labeler code
- 0143
- Product ID
- 0143-9642_c3a41c1b-a9b0-4ad4-83b8-25e56e2c95fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zoledronic acid
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA202182
- Marketing category
- ANDA
- Marketing start
- 2013-06-03
- 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 |
|---|
| 0143-9642-01 | Zoledronic Acid | 5 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 5 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ZOLEDRONIC ACID | ACTIVE INGREDIENT | 6XC1PAD3KF | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [WEST-WARD PHARMACEUTICALS CORP] | 2 | |
| ZOLEDRONIC ACID ANHYDROUS | ACTIVE MOIETY | 70HZ18PH24 | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [WEST-WARD PHARMACEUTICALS CORP] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [WEST-WARD PHARMACEUTICALS CORP] | 2 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [WEST-WARD PHARMACEUTICALS CORP] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [WEST-WARD PHARMACEUTICALS CORP] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9642 | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20220430_784d33fa-0046-42eb-894b-3fc47dcfd4dc.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 |
|---|
| 0143-9642-01 | 00143964201 | 5 mL in 1 VIAL (0143-9642-01) | 5 ml | 2013-06-03 | 0000-00-00 | No | No | Current |