FDA.reportPublic FDA data

Atenolol

Product NDC
68788-4112
11-digit product format
687884112
Labeler code
68788
Product ID
68788-4112_0ad0c7dd-e4e5-4968-9372-7a9bb30073ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213136
Marketing category
ANDA
Marketing start
2026-04-22
Substance
ATENOLOL
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atenolol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50VV3VW0TI
Rxcui197379

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
68788-4112-1Atenolol100 in 1 BOTTLETABLET1001
68788-4112-3Atenolol30 in 1 BOTTLETABLET301
68788-4112-6Atenolol60 in 1 BOTTLETABLET601
68788-4112-9Atenolol90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSN0ad0c7dd-e4e5-4968-9372-7a9bb30073ec1
197379atenolol 100 MG Oral TabletSCD0ad0c7dd-e4e5-4968-9372-7a9bb30073ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4112-168788411201100 TABLET in 1 BOTTLE (68788-4112-1) 100 tablet2026-04-22NoNoHistorical
68788-4112-36878841120330 TABLET in 1 BOTTLE (68788-4112-3) 30 tablet2026-04-22NoNoHistorical
68788-4112-66878841120660 TABLET in 1 BOTTLE (68788-4112-6) 60 tablet2026-04-22NoNoHistorical
68788-4112-96878841120990 TABLET in 1 BOTTLE (68788-4112-9) 90 tablet2026-04-22NoNoHistorical