Betaxolol

Product NDC
24658-701
11-digit product format
246580701
Labeler code
24658
Product ID
24658-701_7ee988e7-153d-4d55-b4ec-1a8da8f78f1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betaxolol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PuraCap Laboratories LLC
Application
ANDA075541
Marketing category
ANDA
Marketing start
2016-08-22
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
24658-701-01Betaxolol100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-701-01EA - Each24658-701b487a07e-ea98-458e-bbf8-7ea5b3ea089c12017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-701BETAXOLOL TABLET, FILM COATED [PURACAP LABORATORIES LLC]4Current NDC, Legacy NDC, 1 package rows20191101_e198244d-fda3-4015-8c01-390f3f88e238.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1297753betaxolol HCl 10 MG Oral TabletPSNe198244d-fda3-4015-8c01-390f3f88e2384
1297757betaxolol HCl 20 MG Oral TabletPSNe198244d-fda3-4015-8c01-390f3f88e2384
1297753betaxolol hydrochloride 10 MG Oral TabletSCDe198244d-fda3-4015-8c01-390f3f88e2384
1297757betaxolol hydrochloride 20 MG Oral TabletSCDe198244d-fda3-4015-8c01-390f3f88e2384
1297757betaxolol hydrochloride (betaxolol 17.88 MG) Oral TabletSYe198244d-fda3-4015-8c01-390f3f88e2384
1297753betaxolol hydrochloride 10 MG (betaxolol 8.94 MG) Oral TabletSYe198244d-fda3-4015-8c01-390f3f88e2384

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24658-701-0124658070101100 TABLET, FILM COATED in 1 BOTTLE (24658-701-01) 2016-12-150000-00-00NoNoCurrent