FDA.reportPublic FDA data

Betaxolol

Product NDC
42806-039
11-digit product format
428060039
Labeler code
42806
Product ID
42806-039_666cb1d9-ec1f-453a-be4f-fafa2b67c1fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betaxolol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Epic Pharma LLC
Application
ANDA075541
Marketing category
ANDA
Marketing start
2010-07-20
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAXOLOL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6X97D2XT0O
Rxcui1297753, 1297757

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-039-01Betaxolol100 in 1 BOTTLETABLET, FILM COATED10012
42806-039-10Betaxolol1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-039-01EA - Each42806-039e1fd8081-86e3-46ce-a492-42360748fbb212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAXOLOL HYDROCHLORIDEACTIVE INGREDIENT6X97D2XT0OBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
BETAXOLOLACTIVE MOIETYO0ZR1R6RZ2BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-039BETAXOLOL TABLET, FILM COATED [EPIC PHARMA LLC]12Current NDC, Legacy NDC, 2 package rows20241222_bf716efe-0a9f-43b1-9d8a-c69330b82e18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297753betaxolol HCl 10 MG Oral TabletPSNbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297757betaxolol HCl 20 MG Oral TabletPSNbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297753betaxolol hydrochloride 10 MG Oral TabletSCDbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297757betaxolol hydrochloride 20 MG Oral TabletSCDbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297757betaxolol hydrochloride (betaxolol 17.88 MG) Oral TabletSYbf716efe-0a9f-43b1-9d8a-c69330b82e1812
1297753betaxolol hydrochloride 10 MG (betaxolol 8.94 MG) Oral TabletSYbf716efe-0a9f-43b1-9d8a-c69330b82e1812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-039-0142806003901100 TABLET, FILM COATED in 1 BOTTLE (42806-039-01) 2010-07-200000-00-00NoNoCurrent
42806-039-10428060039101000 TABLET, FILM COATED in 1 BOTTLE (42806-039-10) 2010-07-200000-00-00NoNoCurrent