Zoledronic acid
- Product NDC
- 43598-255
- 11-digit product format
- 435980255
- Labeler code
- 43598
- Product ID
- 43598-255_9f84a6ad-be66-32f8-d1cc-cc0165058c27
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zoledronic acid
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Dr. Reddy's Laboratories Inc
- Application
- ANDA204344
- Marketing category
- ANDA
- Marketing start
- 2019-01-15
- Substance
- ZOLEDRONIC ACID
- Active strength
- 4 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 | 4 mg/100mL |
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 |
|---|
| 43598-255-52 | Zoledronic acid | 100 mL in 1 BOTTLE | INJECTION, SOLUTION | 100 | | 6 |
| 43598-255-52 | Zoledronic acid | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-255 | ZOLEDRONIC ACID INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20190115_b165df31-52f0-d67f-71e7-f3b4f18d2f15.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 |
|---|
| 43598-255-52 | 43598025552 | 1 BOTTLE in 1 CARTON (43598-255-52) / 100 mL in 1 BOTTLE | 1 bottle | 2019-01-15 | 0000-00-00 | No | No | Current |