zoledronic acid
- Product NDC
- 68083-672
- 11-digit product format
- 680830672
- Labeler code
- 68083
- Product ID
- 68083-672_557bde97-d062-4ad7-b8f4-deb2c5112403
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zoledronic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA219984
- Marketing category
- ANDA
- Marketing start
- 2026-02-05
- Substance
- ZOLEDRONIC ACID
- Active strength
- .04 mg/mL
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- zoledronic acid
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZOLEDRONIC ACID | .04 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6XC1PAD3KF |
| Rxcui | 1114085 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-672-01 | zoledronic acid | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
| 68083-672-01 | zoledronic acid | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-672-01 | 68083067201 | 1 BAG in 1 CARTON (68083-672-01) / 100 mL in 1 BAG | 1 bag | 2026-02-05 | No | No | Current |