FDA.reportPublic FDA data

Atenolol

Product NDC
50090-5363
11-digit product format
500905363
Labeler code
50090
Product ID
50090-5363_7c899e6b-8077-4970-93cb-ff9b374beef9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213136
Marketing category
ANDA
Marketing start
2019-11-21
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
50090-5363-0Atenolol100 in 1 BOTTLETABLET1009
50090-5363-1Atenolol30 in 1 BOTTLETABLET309
50090-5363-4Atenolol60 in 1 BOTTLETABLET609
50090-5363-7Atenolol200 in 1 BOTTLETABLET2009
50090-5363-8Atenolol90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5363-0EA - Each50090-536373775bce-85de-4276-b5bb-aa343050bf9712022-12-07
50090-5363-1EA - Each50090-5363f31e0015-ef21-49e8-a1dd-04b5a7abe7ed12022-12-07
50090-5363-4EA - Each50090-5363ab3fb034-23bc-4f69-ad9c-4fb842ed341312022-12-07
50090-5363-7EA - Each50090-53632f86f646-2222-4d81-94ef-3ab1cf5b564f12022-11-07
50090-5363-8EA - Each50090-5363a3dabab7-e24d-4ce4-b973-237c9ec0ba0312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5363ATENOLOL TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 5 package rows20231217_d3e72119-e3c3-41ba-8787-acc86b44d6c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSNd3e72119-e3c3-41ba-8787-acc86b44d6c49
197381atenolol 50 MG Oral TabletSCDd3e72119-e3c3-41ba-8787-acc86b44d6c49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5363-050090536300100 TABLET in 1 BOTTLE (50090-5363-0) 100 tablet2020-11-170000-00-00NoNoCurrent
50090-5363-15009053630130 TABLET in 1 BOTTLE (50090-5363-1) 30 tablet2022-10-190000-00-00NoNoCurrent
50090-5363-45009053630460 TABLET in 1 BOTTLE (50090-5363-4) 60 tablet2022-10-190000-00-00NoNoCurrent
50090-5363-750090536307200 TABLET in 1 BOTTLE (50090-5363-7) 200 tablet2020-11-170000-00-00NoNoCurrent
50090-5363-85009053630890 TABLET in 1 BOTTLE (50090-5363-8) 90 tablet2020-11-170000-00-00NoNoCurrent