| Product NDC: | 25021-300 | 
| Proprietary Name: | Labetalol | 
| Non Proprietary Name: | Labetalol Hydrochloride | 
| Active Ingredient(s): | 5 mg/mL & nbsp; Labetalol Hydrochloride | 
| Administration Route(s): | INTRAVENOUS | 
| Dosage Form(s): | INJECTION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 25021-300 | 
| Labeler Name: | Sagent Pharmaceuticals | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA079134 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20100217 | 
| Package NDC: | 25021-300-20 | 
| Package Description: | 1 VIAL in 1 CARTON (25021-300-20) > 20 mL in 1 VIAL | 
| NDC Code | 25021-300-20 | 
| Proprietary Name | Labetalol | 
| Package Description | 1 VIAL in 1 CARTON (25021-300-20) > 20 mL in 1 VIAL | 
| Product NDC | 25021-300 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | Labetalol Hydrochloride | 
| Dosage Form Name | INJECTION | 
| Route Name | INTRAVENOUS | 
| Start Marketing Date | 20100217 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Sagent Pharmaceuticals | 
| Substance Name | LABETALOL HYDROCHLORIDE | 
| Strength Number | 5 | 
| Strength Unit | mg/mL | 
| Pharmaceutical Classes | Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC] |