BETAXOLOL HYDROCHLORIDE

Product NDC
10702-014
11-digit product format
107020014
Labeler code
10702
Product ID
10702-014_1757ca78-c783-c977-e063-6294a90a7862
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betaxolol hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
KVK-TECH, INC.
Application
ANDA078962
Marketing category
ANDA
Marketing start
2011-11-02
Substance
BETAXOLOL HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078962-001BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDE10MGTABLET / ORALAB2008-06-27
A078962-002BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDE20MGTABLET / ORALAB2008-06-27

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A078962-001AB
A078962-002AB

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BETAXOLOL HYDROCHLORIDEBETAXOLOL HYDROCHLORIDEKVK-TECH, INC.f3b50bbb-df03-4ed7-9d8d-180edc2abd542024-04-30Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS: Cardiac Failure: Sympathetic stimulation may be a vital component supporting circulatory function in congestive heart failure, and beta-adrenergic receptor blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe heart failure. In hypertensive patients who have congestive heart failure controlled by digitalis and diuretics, beta-blockers should be administered cautiously. Both digitalis and beta-adrenergic receptor blocking agents slow AV conduction. In Patients Without a History of Cardiac Failure: Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. Therefore, at the first sign or symptom of cardiac failure, discontinuation of betaxolol tablets, USP should be considered. In some cases beta-blocker therapy can be continued while cardiac failure is treated with cardiac glycosides, diuretics, and other agents, as appropriate. Exacerbation of Angina Pectoris Upon Withdrawal: Abrupt cessation of therapy with certain beta-blocking agents in patients with coronary artery disease has been followed by exacerbations of angina pectoris and, in some cases, myocardial infarction has been reported. Therefore such patients should be warned against interruption of therapy without the physician’s advice. Even in the absence of overt angina pectoris, when discontinuation of betaxolol tablets, USP is planned, the patient should be carefully observed and therapy should be reinstituted, at least temporarily, if withdrawal symptoms occur. Bronchospastic diseases: PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD NOT IN GENERAL RECEIVE BETA-BLOCKERS. Because of its relative ß 1 selectivity (cardioselectivity), low doses of betaxolol tablets, USP may be used with caution in patients with bronchospastic disease who do not respond to or cannot tolerate alternative treatment. Since ß 1 selectivity is not absolute and is inversely related to dose, the lowest possible dose of betaxolol tablets, USP should be used (5 to 10 mg once daily) and a bronchodilator should be made available. If dosage must be increased, divided dosage should be considered to avoid the higher peak blood levels associated with once-daily dosing. Major Surgery: Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

ADVERSE REACTIONS: Most adverse reactions have been mild and transient and are typical of beta-adrenergic blocking agents, e.g., bradycardia, fatigue, dyspnea, and lethargy. Withdrawal of therapy in U.S. and European controlled clinical trials has been necessary in about 3.5% of patients, principally because of bradycardia, fatigue, dizziness, headache, and impotence. Frequency estimates of adverse events were derived from controlled studies in which adverse reactions were volunteered and elicited in U.S. studies and volunteered and/or elicited in European studies. In the U.S., the placebo-controlled hypertension studies lasted for 4 weeks, while the active-controlled hypertension studies has a 22- to 24- week double-blind phase. The following doses were studied: Betaxolol tablets, USP-5, 10, 20, and 40 mg once daily; atenolol-25, 50, and 100 mg once daily; and propranolol-40, 80, and 160 mg b.i.d. Betaxolol tablets, USP, like other beta-blockers, has been associated with the development of antinuclear antibodies (ANA) (e.g. lupus erythematosus). In controlled clinical studies, conversion of ANA from negative to positive occurred in 5.3% of the patients treated with betaxolol tablets, USP, 6.3% of the patients treated with atenolol, 4.9% of the patients treated with propranolol, and 3.2% of the patients treated with placebo. Betaxolol adverse events reported with a 2% or greater frequency, and selected events with lower frequency, in U.S. controlled studies are: Of the above adverse reactions associated with the use of betaxolol, only bradycardia was clearly dose related, but there was a suggestion of dose relatedness for fatigue, lethargy, and dyspepsia. In Europe, the placebo-controlled study lasted for 4 weeks, while the comparative studies had a 4- to 52-week double-blind phase. The following doses were studied: Betaxolol 20 and 40 mg once daily and atenolol 100 mg once daily. From European controlled hypertension clinical trials, the following adverse events reported by 2% or more patients and selected events with lower frequency are presented: The only adverse event whose frequency clearly rose with increasing dose was bradycardia. Elderly patients were especially susceptible to bradycardia, which in some cases responded to dose-reduction (see Precautions ). The following selected (potentially important) adverse events have been reported at an incid...

Additional Listing Data#

Finished product
Yes
Brand name base
BETAXOLOL HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAXOLOL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6X97D2XT0O
Rxcui1297753, 1297757

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-014-012024-02-14C16284748780-11030e364-fb7f-111a-e063-dadaa90a10e2Betaxolol Tablets, USP
10702-014-012024-01-30C16284748780-11030e364-fb7f-111a-e063-dadaa90a10e2Betaxolol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-014-01BETAXOLOL HYDROCHLORIDE100 in 1 BOTTLETABLET, COATED10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-014-01EA - Each10702-0140406f531-4fdb-4874-b927-f3751545959112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAXOLOL HYDROCHLORIDEACTIVE INGREDIENT6X97D2XT0OBETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
BETAXOLOLACTIVE MOIETYO0ZR1R6RZ2BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]4
BETAXOLOL HYDROCHLORIDEACTIVE INGREDIENT6X97D2XT0OBETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
BETAXOLOLACTIVE MOIETYO0ZR1R6RZ2BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBETAXOLOL TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-014BETAXOLOL HYDROCHLORIDE TABLET, COATED [KVK-TECH, INC.]10Current NDC, Legacy NDC, 1 package rows20240502_f3b50bbb-df03-4ed7-9d8d-180edc2abd54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297753betaxolol HCl 10 MG Oral TabletPSNf3b50bbb-df03-4ed7-9d8d-180edc2abd5410
1297757betaxolol HCl 20 MG Oral TabletPSNf3b50bbb-df03-4ed7-9d8d-180edc2abd5410
1297753betaxolol hydrochloride 10 MG Oral TabletSCDf3b50bbb-df03-4ed7-9d8d-180edc2abd5410
1297757betaxolol hydrochloride 20 MG Oral TabletSCDf3b50bbb-df03-4ed7-9d8d-180edc2abd5410
1297757betaxolol hydrochloride (betaxolol 17.88 MG) Oral TabletSYf3b50bbb-df03-4ed7-9d8d-180edc2abd5410
1297753betaxolol hydrochloride 10 MG (betaxolol 8.94 MG) Oral TabletSYf3b50bbb-df03-4ed7-9d8d-180edc2abd5410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10702-014-0110702001401100 TABLET, COATED in 1 BOTTLE (10702-014-01) 2011-11-020000-00-00NoNoCurrent