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NDC 00517-1045-05 Levocarnitine 200 mg/mL Details
Levocarnitine 200 mg/mL
Levocarnitine is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by American Regent, Inc.. The primary component is LEVOCARNITINE.
Product Information
| NDC | 00517-1045 |
|---|---|
| Product ID | 0517-1045_6da188f1-f972-4949-9764-da02eb63d113 |
| Associated GPIs | |
| GCN Sequence Number | 046990 |
| GCN Sequence Number Description | levocarnitine VIAL 200 MG/ML INTRAVEN |
| HIC3 | C7D |
| HIC3 Description | METABOLIC DEFICIENCY AGENTS |
| GCN | 85421 |
| HICL Sequence Number | 000859 |
| HICL Sequence Number Description | LEVOCARNITINE |
| Brand/Generic | Generic |
| Proprietary Name | Levocarnitine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Levocarnitine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/mL |
| Substance Name | LEVOCARNITINE |
| Labeler Name | American Regent, Inc. |
| Pharmaceutical Class | Carnitine Analog [EPC], Carnitine [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075861 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00517-1045-05 (00517104505)
| NDC Package Code | 0517-1045-05 |
|---|---|
| Billing NDC | 00517104505 |
| Package | 5 VIAL, SINGLE-DOSE in 1 TRAY (0517-1045-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-1045-01) |
| Marketing Start Date | 2023-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |