| Product NDC: | 68083-111 |
| Proprietary Name: | Labetalol Hydrochloride |
| Non Proprietary Name: | Labetalol Hydrochloride |
| Active Ingredient(s): | 5 mg/mL & nbsp; Labetalol Hydrochloride |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68083-111 |
| Labeler Name: | Gland Pharma Limited |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA090699 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120419 |
| Package NDC: | 68083-111-01 |
| Package Description: | 10 VIAL, GLASS in 1 CARTON (68083-111-01) > 20 mL in 1 VIAL, GLASS |
| NDC Code | 68083-111-01 |
| Proprietary Name | Labetalol Hydrochloride |
| Package Description | 10 VIAL, GLASS in 1 CARTON (68083-111-01) > 20 mL in 1 VIAL, GLASS |
| Product NDC | 68083-111 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Labetalol Hydrochloride |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20120419 |
| Marketing Category Name | ANDA |
| Labeler Name | Gland Pharma Limited |
| Substance Name | LABETALOL HYDROCHLORIDE |
| Strength Number | 5 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] |