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NDC 71288-0806-51 Zoledronic Acid 5 mg/100mL Details
Zoledronic Acid 5 mg/100mL
Zoledronic Acid is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is ZOLEDRONIC ACID.
Product Information
| NDC | 71288-0806 |
|---|---|
| Product ID | 71288-806_a4589df5-8c10-4040-ba54-637c518a0e11 |
| Associated GPIs | |
| GCN Sequence Number | 059404 |
| GCN Sequence Number Description | zoledronic acid/mannitol-water PGGYBK BTL 5 MG/100ML INTRAVEN |
| HIC3 | P4L |
| HIC3 Description | BONE RESORPTION INHIBITORS |
| GCN | 25026 |
| HICL Sequence Number | 034717 |
| HICL Sequence Number Description | ZOLEDRONIC ACID IN MANNITOL AND WATER FOR INJECTION |
| Brand/Generic | Generic |
| Proprietary Name | Zoledronic Acid |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zoledronic Acid |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/100mL |
| Substance Name | ZOLEDRONIC ACID |
| Labeler Name | Meitheal Pharmaceuticals Inc. |
| Pharmaceutical Class | Bisphosphonate [EPC], Diphosphonates [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213371 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71288-0806-51 (71288080651)
| NDC Package Code | 71288-806-51 |
|---|---|
| Billing NDC | 71288080651 |
| Package | 1 BOTTLE, GLASS in 1 CARTON (71288-806-51) / 100 mL in 1 BOTTLE, GLASS |
| Marketing Start Date | 2023-06-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |