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NDC 47781-0586-29 Labetalol Hydrochloride 5 mg/mL Details
Labetalol Hydrochloride 5 mg/mL
Labetalol Hydrochloride is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alvogen Inc.. The primary component is LABETALOL HYDROCHLORIDE.
Product Information
NDC | 47781-0586 |
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Product ID | 47781-586_d59ca248-8648-4aa8-87b4-a6de2f7d14e6 |
Associated GPIs | 33300010102005 |
GCN Sequence Number | 005097 |
GCN Sequence Number Description | labetalol HCl VIAL 5 MG/ML INTRAVEN |
HIC3 | J7A |
HIC3 Description | ALPHA/BETA-ADRENERGIC BLOCKING AGENTS |
GCN | 18990 |
HICL Sequence Number | 002095 |
HICL Sequence Number Description | LABETALOL HCL |
Brand/Generic | Generic |
Proprietary Name | Labetalol Hydrochloride |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Labetalol Hydrochloride |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 5 |
Active Ingredient Units | mg/mL |
Substance Name | LABETALOL HYDROCHLORIDE |
Labeler Name | Alvogen Inc. |
Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA090699 |
Listing Certified Through | 2024-12-31 |
Package
NDC 47781-0586-29 (47781058629)
NDC Package Code | 47781-586-29 |
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Billing NDC | 47781058629 |
Package | 1 VIAL, MULTI-DOSE in 1 CARTON (47781-586-29) / 20 mL in 1 VIAL, MULTI-DOSE |
Marketing Start Date | 2017-06-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |