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NDC 63629-9185-01 Labetalol HCL 300 mg/1 Details
Labetalol HCL 300 mg/1
Labetalol HCL is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is LABETALOL HYDROCHLORIDE.
MedlinePlus Drug Summary
Labetalol is used to treat high blood pressure. Labetalol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
Related Packages: 63629-9185-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Labetalol
Product Information
| NDC | 63629-9185 |
|---|---|
| Product ID | 63629-9185_fce6ebc7-e44a-4d7d-84ca-7425ad8f2749 |
| Associated GPIs | |
| GCN Sequence Number | 005100 |
| GCN Sequence Number Description | labetalol HCl TABLET 300 MG ORAL |
| HIC3 | J7A |
| HIC3 Description | ALPHA/BETA-ADRENERGIC BLOCKING AGENTS |
| GCN | 10340 |
| HICL Sequence Number | 002095 |
| HICL Sequence Number Description | LABETALOL HCL |
| Brand/Generic | Generic |
| Proprietary Name | Labetalol HCL |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Labetalol Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/1 |
| Substance Name | LABETALOL HYDROCHLORIDE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA200908 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 63629-9185-01 (63629918501)
| NDC Package Code | 63629-9185-1 |
|---|---|
| Billing NDC | 63629918501 |
| Package | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-9185-1) |
| Marketing Start Date | 2022-08-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |