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: | 68083-111-02 |
Package Description: | 10 VIAL, GLASS in 1 CARTON (68083-111-02) > 40 mL in 1 VIAL, GLASS |
NDC Code | 68083-111-02 |
Proprietary Name | Labetalol Hydrochloride |
Package Description | 10 VIAL, GLASS in 1 CARTON (68083-111-02) > 40 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] |