Betaxolol Hydrochloride

Product NDC
61314-245
11-digit product format
613140245
Labeler code
61314
Product ID
61314-245_c30e555b-1a79-4c3e-b79d-8c1d950fd832
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betaxolol Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Sandoz Inc
Application
NDA019270
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2000-05-15
Substance
BETAXOLOL HYDROCHLORIDE
Active strength
5.6 mg/mL
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 HYDROCHLORIDE5.6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6X97D2XT0O
Rxcui308720

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61314-245-01Betaxolol Hydrochloride5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS59
61314-245-01Betaxolol Hydrochloride1 in 1 CARTONSOLUTION/ DROPS19
61314-245-02Betaxolol Hydrochloride15 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS159
61314-245-02Betaxolol Hydrochloride1 in 1 CARTONSOLUTION/ DROPS19
61314-245-03Betaxolol Hydrochloride10 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS109
61314-245-03Betaxolol Hydrochloride1 in 1 CARTONSOLUTION/ DROPS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61314-245-01ML - Milliliter61314-24512b7f746-0fa7-4db4-8a3c-3091af7d1afa12012-07-24
61314-245-02ML - Milliliter61314-245a47db180-c7fd-49db-886f-47abe3e77d8412012-07-24
61314-245-03ML - Milliliter61314-245180315e8-5352-4bab-98bc-4f68d602558712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAXOLOL HYDROCHLORIDEACTIVE INGREDIENT6X97D2XT0OBETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]4
BETAXOLOLACTIVE MOIETYO0ZR1R6RZ2BETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7BETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]4
WATERINACTIVE INGREDIENT059QF0KO0RBETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61314-245BETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC]9Current NDC, Legacy NDC, 6 package rows20231121_a73519d5-546c-4377-92ed-0d4be2685d60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308720betaxolol HCl 0.5 % Ophthalmic SolutionPSNa73519d5-546c-4377-92ed-0d4be2685d609
308720betaxolol 5 MG/ML Ophthalmic SolutionSCDa73519d5-546c-4377-92ed-0d4be2685d609
308720betaxolol 0.5 % Ophthalmic SolutionSYa73519d5-546c-4377-92ed-0d4be2685d609
308720betaxolol 5 MG/ML (betaxolol hydrochloride 5.6 MG/ML) Ophthalmic SolutionSYa73519d5-546c-4377-92ed-0d4be2685d609

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61314-245-01613140245011 BOTTLE, PLASTIC in 1 CARTON (61314-245-01) / 5 mL in 1 BOTTLE, PLASTIC2000-05-150000-00-00NoNoCurrent
61314-245-02613140245021 BOTTLE, PLASTIC in 1 CARTON (61314-245-02) / 15 mL in 1 BOTTLE, PLASTIC2000-05-150000-00-00NoNoCurrent
61314-245-03613140245031 BOTTLE, PLASTIC in 1 CARTON (61314-245-03) / 10 mL in 1 BOTTLE, PLASTIC2000-05-150000-00-00NoNoCurrent