FDA.reportPublic FDA data

Betaxolol

Product NDC
17478-705
11-digit product format
174780705
Labeler code
17478
Product ID
17478-705_279440fe-a010-49be-98bc-bfa70a222438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betaxolol Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA075386
Marketing category
ANDA
Marketing start
2003-04-01
Marketing end
0000-00-00
Substance
BETAXOLOL HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-705-102024-01-30C16284748780-11030e365-15a0-111a-e063-dadaa90a10e21fc0a413-4e6b-4ed7-9957-ace4c8cfab55
17478-705-112024-01-30C16284748780-11030e365-15a0-111a-e063-dadaa90a10e21fc0a413-4e6b-4ed7-9957-ace4c8cfab55
17478-705-122024-01-30C16284748780-11030e365-15a0-111a-e063-dadaa90a10e21fc0a413-4e6b-4ed7-9957-ace4c8cfab55
17478-705-252024-01-30C16284748780-11030e365-15a0-111a-e063-dadaa90a10e21fc0a413-4e6b-4ed7-9957-ace4c8cfab55

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-705-10Betaxolol1 in 1 CARTONSOLUTION/ DROPS15
17478-705-10Betaxolol5 mL in 1 VIALSOLUTION/ DROPS55
17478-705-11Betaxolol1 in 1 CARTONSOLUTION/ DROPS15
17478-705-11Betaxolol10 mL in 1 VIALSOLUTION/ DROPS105
17478-705-12Betaxolol15 mL in 1 VIALSOLUTION/ DROPS155
17478-705-12Betaxolol1 in 1 CARTONSOLUTION/ DROPS15
17478-705-25Betaxolol2.5 mL in 1 VIALSOLUTION/ DROPS2.55
17478-705-25Betaxolol1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-705-10ML - Milliliter17478-7056a611f71-acdc-46c6-9ddb-98fcf37ba7de12012-07-24
17478-705-11ML - Milliliter17478-705ecb50b52-9bd1-4cab-8830-e6a2e5c634a912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Betaxolol HydrochlorideACTIVE INGREDIENT6X97D2XT0OBETAXOLOL (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [AKORN, INC.]1
BetaxololACTIVE MOIETYO0ZR1R6RZ2BETAXOLOL (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [AKORN, INC.]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7BETAXOLOL (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [AKORN, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KBETAXOLOL (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [AKORN, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBBETAXOLOL (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [AKORN, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XBETAXOLOL (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [AKORN, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IBETAXOLOL (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [AKORN, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-705BETAXOLOL (BETAXOLOL HYDROCHLORIDE) SOLUTION/ DROPS [AKORN]5Legacy NDC, 8 package rows20220524_1fc0a413-4e6b-4ed7-9957-ace4c8cfab55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308720betaxolol HCl 0.5 % Ophthalmic SolutionPSN1fc0a413-4e6b-4ed7-9957-ace4c8cfab555
308720betaxolol 5 MG/ML Ophthalmic SolutionSCD1fc0a413-4e6b-4ed7-9957-ace4c8cfab555
308720betaxolol 0.5 % Ophthalmic SolutionSY1fc0a413-4e6b-4ed7-9957-ace4c8cfab555
308720betaxolol 5 MG/ML (betaxolol hydrochloride 5.6 MG/ML) Ophthalmic SolutionSY1fc0a413-4e6b-4ed7-9957-ace4c8cfab555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-705-10174780705101 VIAL in 1 CARTON (17478-705-10) > 5 mL in 1 VIAL1 vial2003-04-010000-00-00NoNoCurrent
17478-705-11174780705111 VIAL in 1 CARTON (17478-705-11) > 10 mL in 1 VIAL1 vial2003-04-010000-00-00NoNoCurrent
17478-705-12174780705121 VIAL in 1 CARTON (17478-705-12) > 15 mL in 1 VIAL1 vial2003-04-010000-00-00NoNoCurrent
17478-705-25174780705251 VIAL in 1 CARTON (17478-705-25) > 2.5 mL in 1 VIAL1 vial2003-04-010000-00-00NoNoCurrent