FDA.reportPublic FDA data

Atenolol

Product NDC
50090-5738
11-digit product format
500905738
Labeler code
50090
Product ID
50090-5738_25bc96b5-0c59-49cd-9d2c-d56db5915479
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078512
Marketing category
ANDA
Marketing start
2007-10-31
Substance
ATENOLOL
Active strength
100 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5738-02023-02-07C16284748780-1f386c649-e82a-0266-e053-dadaa90a7c1aAtenolol Tablets, USP Rx only
50090-5738-32023-02-07C16284748780-1f386c649-e82a-0266-e053-dadaa90a7c1aAtenolol Tablets, USP Rx only
50090-5738-52023-02-07C16284748780-1f386c649-e82a-0266-e053-dadaa90a7c1aAtenolol Tablets, USP Rx only
50090-5738-02023-01-30C16284748780-1f386c649-e82a-0266-e053-dadaa90a7c1aAtenolol Tablets, USP Rx only
50090-5738-32023-01-30C16284748780-1f386c649-e82a-0266-e053-dadaa90a7c1aAtenolol Tablets, USP Rx only
50090-5738-52023-01-30C16284748780-1f386c649-e82a-0266-e053-dadaa90a7c1aAtenolol Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5738-0Atenolol30 in 1 BOTTLETABLET305
50090-5738-3Atenolol60 in 1 BOTTLETABLET605
50090-5738-5Atenolol90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5738-0EA - Each50090-57389220dccd-e24f-407a-9716-12527da5f0c612022-08-04
50090-5738-3EA - Each50090-57387086645a-26ec-4d98-9891-659d7bafcdba12022-08-04
50090-5738-5EA - Each50090-5738698382cf-0a4b-41c0-abe0-75f85ed58c3912022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5738ATENOLOL TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20231204_a0e3b2a5-5ea1-4549-8144-bd059f7966f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSNa0e3b2a5-5ea1-4549-8144-bd059f7966f05
197379atenolol 100 MG Oral TabletSCDa0e3b2a5-5ea1-4549-8144-bd059f7966f05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5738-05009057380030 TABLET in 1 BOTTLE (50090-5738-0) 30 tablet2021-09-290000-00-00NoNoCurrent
50090-5738-35009057380360 TABLET in 1 BOTTLE (50090-5738-3) 60 tablet2021-09-290000-00-00NoNoCurrent
50090-5738-55009057380590 TABLET in 1 BOTTLE (50090-5738-5) 90 tablet2021-09-290000-00-00NoNoCurrent