Zoledronic Acid
- Product NDC
- 17478-327
- 11-digit product format
- 174780327
- Labeler code
- 17478
- Product ID
- 17478-327_a8e4a09f-afe8-41ff-b53c-14182070d102
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zoledronic Acid
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Akorn
- Application
- ANDA202548
- Marketing category
- ANDA
- Marketing start
- 2014-05-22
- Marketing end
- 0000-00-00
- Substance
- ZOLEDRONIC ACID
- Active strength
- 4 mg/5mL
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17478-327-05 | Zoledronic Acid | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 8 |
| 17478-327-05 | Zoledronic Acid | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 5 | | 8 |
| 17478-327-45 | Zoledronic Acid | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 5 | | 8 |
| 17478-327-45 | Zoledronic Acid | 4 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 4 | | 8 |
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 [AKORN] | 2 | |
| Zoledronic Acid Anhydrous | ACTIVE MOIETY | 70HZ18PH24 | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [AKORN] | 2 | |
| Mannitol | INACTIVE INGREDIENT | 3OWL53L36A | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [AKORN] | 2 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [AKORN] | 2 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [AKORN] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-327 | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [AKORN] | 8 | Legacy NDC, 4 package rows | 20220922_2191fccc-9f90-486c-8f30-dc828b62fe15.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 17478-327-05 | 17478032705 | 1 VIAL, SINGLE-USE in 1 CARTON (17478-327-05) > 5 mL in 1 VIAL, SINGLE-USE | 2014-05-22 | 0000-00-00 | No | No | Current |
| 17478-327-45 | 17478032745 | 4 VIAL, SINGLE-USE in 1 CARTON (17478-327-45) > 5 mL in 1 VIAL, SINGLE-USE | 2014-05-22 | 0000-00-00 | No | No | Current |