FDA.reportPublic FDA data

Atenolol

Product NDC
50090-0442
11-digit product format
500900442
Labeler code
50090
Product ID
50090-0442_e9ed62e3-8fa6-4d23-b71f-1d0fb9b1e9cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076900
Marketing category
ANDA
Marketing start
2005-10-08
Substance
ATENOLOL
Active strength
50 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0442-02023-01-30C16284748780-1f386c64a-1673-0266-e053-dadaa90a7c1aAtenolol Tablets, USP
50090-0442-12023-01-30C16284748780-1f386c64a-1673-0266-e053-dadaa90a7c1aAtenolol Tablets, USP
50090-0442-42023-01-30C16284748780-1f386c64a-1673-0266-e053-dadaa90a7c1aAtenolol Tablets, USP
50090-0442-72023-01-30C16284748780-1f386c64a-1673-0266-e053-dadaa90a7c1aAtenolol Tablets, USP
50090-0442-82023-01-30C16284748780-1f386c64a-1673-0266-e053-dadaa90a7c1aAtenolol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0442-0Atenolol100 in 1 BOTTLETABLET10016
50090-0442-1Atenolol30 in 1 BOTTLETABLET3016
50090-0442-4Atenolol60 in 1 BOTTLETABLET6016
50090-0442-7Atenolol200 in 1 BOTTLETABLET20016
50090-0442-8Atenolol90 in 1 BOTTLETABLET9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0442-0EA - Each50090-04421ae4d1d4-390b-4717-8aa3-3825ab7cfcaf12018-08-13
50090-0442-1EA - Each50090-04424d54f1f4-81de-48b5-b64e-a91b947781c012018-09-05
50090-0442-4EA - Each50090-04423074aad8-8fa5-43b7-b381-318c125fe44012018-09-05
50090-0442-7EA - Each50090-0442f1696d04-cc40-4554-8c69-ff50ee53278c12018-09-05
50090-0442-8EA - Each50090-04425fed7b68-7c67-47e2-a1df-a7d7b5c9539c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0442ATENOLOL TABLET [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 5 package rows20210415_d21f2b4d-6584-48e5-8045-e5927ba03329.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSNd21f2b4d-6584-48e5-8045-e5927ba0332916
197381atenolol 50 MG Oral TabletSCDd21f2b4d-6584-48e5-8045-e5927ba0332916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0442-050090044200100 TABLET in 1 BOTTLE (50090-0442-0) 100 tablet2016-06-290000-00-00NoNoCurrent
50090-0442-15009004420130 TABLET in 1 BOTTLE (50090-0442-1) 30 tablet2016-06-290000-00-00NoNoCurrent
50090-0442-45009004420460 TABLET in 1 BOTTLE (50090-0442-4) 60 tablet2016-06-290000-00-00NoNoCurrent
50090-0442-750090044207200 TABLET in 1 BOTTLE (50090-0442-7) 200 tablet2016-06-290000-00-00NoNoCurrent
50090-0442-85009004420890 TABLET in 1 BOTTLE (50090-0442-8) 90 tablet2016-06-290000-00-00NoNoCurrent