BETAXOLOL HYDROCHLORIDE

Product NDC
10702-013
11-digit product format
107020013
Labeler code
10702
Product ID
10702-013_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
10 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAXOLOL HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6X97D2XT0O
Rxcui1297753, 1297757

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-013-012024-02-14C16284748780-11030e364-fb7f-111a-e063-dadaa90a10e2Betaxolol Tablets, USP
10702-013-012024-01-30C16284748780-11030e364-fb7f-111a-e063-dadaa90a10e2Betaxolol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-013-01BETAXOLOL HYDROCHLORIDE100 in 1 BOTTLETABLET, COATED10010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-013BETAXOLOL 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
10702-013-0110702001301100 TABLET, COATED in 1 BOTTLE (10702-013-01) 2011-11-020000-00-00NoNoCurrent