Betaxolol

Product NDC
10135-624
11-digit product format
101350624
Labeler code
10135
Product ID
10135-624_57968420-5df5-4b0c-ab16-5bb526a908e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betaxolol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA075541
Marketing category
ANDA
Marketing start
2016-07-01
Marketing end
0000-00-00
Substance
BETAXOLOL HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-624-012020-01-31C16284748780-19d75b9d1-11be-f424-e053-dadaa90a57ceBetaxolol Tablets USP, Film-Coated

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-624-01Betaxolol100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-624-01EA - Each10135-624bba88f6a-7e79-4e8e-9d23-02bb4945b88212016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-624BETAXOLOL TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 1 package rows20161005_4aa6e51b-80a3-4022-87e2-0692f24ae9ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297753betaxolol HCl 10 MG Oral TabletPSN4aa6e51b-80a3-4022-87e2-0692f24ae9ca1
1297757betaxolol HCl 20 MG Oral TabletPSN4aa6e51b-80a3-4022-87e2-0692f24ae9ca1
1297753betaxolol hydrochloride 10 MG Oral TabletSCD4aa6e51b-80a3-4022-87e2-0692f24ae9ca1
1297757betaxolol hydrochloride 20 MG Oral TabletSCD4aa6e51b-80a3-4022-87e2-0692f24ae9ca1
1297757betaxolol hydrochloride (betaxolol 17.88 MG) Oral TabletSY4aa6e51b-80a3-4022-87e2-0692f24ae9ca1
1297753betaxolol hydrochloride 10 MG (betaxolol 8.94 MG) Oral TabletSY4aa6e51b-80a3-4022-87e2-0692f24ae9ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-624-0110135062401100 in 1 BOTTLEHistorical