Zoledronic Acid
- Product NDC
- 69367-190
- 11-digit product format
- 693670190
- Labeler code
- 69367
- Product ID
- 69367-190_ae589b16-5f97-4550-bfc4-5ccf316336fd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zoledronic Acid
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- ANDA202923
- Marketing category
- ANDA
- Marketing start
- 2023-02-02
- Marketing end
- 2026-12-01
- Substance
- ZOLEDRONIC ACID
- Active strength
- 4 mg/5mL
- Pharmacologic classes
- Bisphosphonate [EPC], Diphosphonates [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zoledronic Acid
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 |
|---|
| 69367-190-50 | Zoledronic Acid | 1 in 1 CARTON | INJECTION | 1 | | 3 |
| 69367-190-50 | Zoledronic Acid | 5 mL in 1 VIAL | INJECTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-190 | ZOLEDRONIC ACID INJECTION [WESTMINSTER PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20230211_6a153c94-3cb5-4c05-98b2-1e18f5f3fe80.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 |
|---|
| 69367-190-50 | 69367019050 | 1 VIAL in 1 CARTON (69367-190-50) / 5 mL in 1 VIAL | 1 vial | 2023-02-02 | 2026-12-01 | No | No | Historical |