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NDC 10135-0713-05 Labetalol Hydrochloride 300 mg/1 Details
Labetalol Hydrochloride 300 mg/1
Labetalol Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is LABETALOL.
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: 10135-0713-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Labetalol
Product Information
| NDC | 10135-0713 |
|---|---|
| Product ID | 10135-713_097eac26-5331-0f27-e063-6294a90ae0c5 |
| 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 Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Labetalol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 300 |
| Active Ingredient Units | mg/1 |
| Substance Name | LABETALOL |
| Labeler Name | Marlex Pharmaceuticals Inc |
| Pharmaceutical Class | Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075215 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 10135-0713-05 (10135071305)
| NDC Package Code | 10135-713-05 |
|---|---|
| Billing NDC | 10135071305 |
| Package | 500 TABLET, FILM COATED in 1 BOTTLE (10135-713-05) |
| Marketing Start Date | 2020-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |