Zoledronic Acid
- Product NDC
- 71288-806
- 11-digit product format
- 712880806
- Labeler code
- 71288
- Product ID
- 71288-806_a4589df5-8c10-4040-ba54-637c518a0e11
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zoledronic Acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA213371
- Marketing category
- ANDA
- Marketing start
- 2023-06-05
- Substance
- ZOLEDRONIC ACID
- Active strength
- 5 mg/100mL
- 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 | 5 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6XC1PAD3KF |
| Rxcui | 705824 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71288-806-51 | Zoledronic Acid | 100 mL in 1 BOTTLE, GLASS | INJECTION, SOLUTION | 100 | | 1 |
| 71288-806-51 | Zoledronic Acid | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-806 | ZOLEDRONIC ACID INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 1 | Current NDC, 2 package rows | 20230613_8aac81ae-f92c-4f0b-b480-44badf72b5f5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71288-806-51 | 71288080651 | 1 BOTTLE, GLASS in 1 CARTON (71288-806-51) / 100 mL in 1 BOTTLE, GLASS | 2023-06-05 | No | No | Current |