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NDC 39822-1030-02 Ibuprofen Lysine 10 mg/mL Details
Ibuprofen Lysine 10 mg/mL
Ibuprofen Lysine is a INTRAVENOUS SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by XGen Pharmaceuticals DJB, Inc.. The primary component is IBUPROFEN LYSINE.
Product Information
| NDC | 39822-1030 |
|---|---|
| Product ID | 39822-1030_09c10e65-0cea-3052-e063-6394a90ae199 |
| Associated GPIs | 66100020402010 |
| GCN Sequence Number | 060994 |
| GCN Sequence Number Description | ibuprofen lysine/PF VIAL 20 MG/2 ML INTRAVEN |
| HIC3 | A5A |
| HIC3 Description | PATENT DUCTUS ARTERIOSUS TREAT. AGENTS, NSAID-TYPE |
| GCN | 27148 |
| HICL Sequence Number | 033810 |
| HICL Sequence Number Description | IBUPROFEN LYSINE/PF |
| Brand/Generic | Generic |
| Proprietary Name | Ibuprofen Lysine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ibuprofen Lysine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | IBUPROFEN LYSINE |
| Labeler Name | XGen Pharmaceuticals DJB, Inc. |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA202402 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 39822-1030-02 (39822103002)
| NDC Package Code | 39822-1030-2 |
|---|---|
| Billing NDC | 39822103002 |
| Package | 3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1) |
| Marketing Start Date | 2016-04-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |