Zoledronic Acid
- Product NDC
- 68083-116
- 11-digit product format
- 680830116
- Labeler code
- 68083
- Product ID
- 68083-116_c08f4eee-1566-4493-83f7-48fa1319a234
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zoledronic acid
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA202930
- Marketing category
- ANDA
- Marketing start
- 2013-09-20
- Substance
- ZOLEDRONIC ACID
- Active strength
- 4 mg/5mL
- 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/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 |
|---|
| 68083-116-01 | Zoledronic Acid | 5 mL in 1 VIAL | INJECTION, SOLUTION, CONCENTRATE | 5 | | 21 |
| 68083-116-01 | Zoledronic Acid | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 21 |
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 [GLAND PHARMA LIMITED] | 12 | |
| ZOLEDRONIC ACID ANHYDROUS | ACTIVE MOIETY | 70HZ18PH24 | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [GLAND PHARMA LIMITED] | 12 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [GLAND PHARMA LIMITED] | 12 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [GLAND PHARMA LIMITED] | 12 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [GLAND PHARMA LIMITED] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-116 | ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE [GLAND PHARMA LIMITED] | 21 | Current NDC, Legacy NDC, 2 package rows | 20231121_7a5e8962-7c4b-40bb-ad69-0c3edb0338af.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 |
|---|
| 68083-116-01 | 68083011601 | 1 VIAL in 1 CARTON (68083-116-01) / 5 mL in 1 VIAL | 1 vial | 2013-09-20 | 0000-00-00 | No | No | Current |