FDA.reportPublic FDA data

Atenolol

Product NDC
68788-8834
11-digit product format
687888834
Labeler code
68788
Product ID
68788-8834_0f744371-94fa-419d-bfed-b22301dde8b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078512
Marketing category
ANDA
Marketing start
2025-02-21
Substance
ATENOLOL
Active strength
50 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
Atenolol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50VV3VW0TI
Rxcui197381

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8834-1Atenolol100 in 1 BOTTLETABLET1001
68788-8834-3Atenolol30 in 1 BOTTLETABLET301
68788-8834-6Atenolol60 in 1 BOTTLETABLET601
68788-8834-9Atenolol90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8834-1EA - Each68788-8834a538400d-7407-4e02-bcba-4a056d3d63e612025-05-14
68788-8834-3EA - Each68788-88343ec285e3-298f-4aa2-8e40-17c46ed6025012025-05-14
68788-8834-6EA - Each68788-8834e6858572-634a-4388-96ee-6a4ef69eb67612025-05-14
68788-8834-9EA - Each68788-8834ac821b07-50ce-49a9-b1ec-3a876bb65ac412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8834ATENOLOL TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20250224_0f744371-94fa-419d-bfed-b22301dde8b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSN0f744371-94fa-419d-bfed-b22301dde8b81
197381atenolol 50 MG Oral TabletSCD0f744371-94fa-419d-bfed-b22301dde8b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8834-168788883401100 TABLET in 1 BOTTLE (68788-8834-1) 100 tablet2025-02-21NoNoCurrent
68788-8834-36878888340330 TABLET in 1 BOTTLE (68788-8834-3) 30 tablet2025-02-21NoNoCurrent
68788-8834-66878888340660 TABLET in 1 BOTTLE (68788-8834-6) 60 tablet2025-02-21NoNoCurrent
68788-8834-96878888340990 TABLET in 1 BOTTLE (68788-8834-9) 90 tablet2025-02-21NoNoCurrent