FDA.reportPublic FDA data

Atenolol

Product NDC
51655-709
11-digit product format
516550709
Labeler code
51655
Product ID
51655-709_4b946cc9-d023-35f7-e063-6294a90a9438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA077443
Marketing category
ANDA
Marketing start
2021-05-07
Substance
ATENOLOL
Active strength
25 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
ATENOLOL25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50VV3VW0TI
Rxcui197380

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
51655-709-262026-01-29C16284748780-149896155-c19a-586f-e063-e6dba90add90Atenolol Tablets USP 25 mg, 50 mg and 100 mgRx only
51655-709-522026-01-29C16284748780-149896155-c19a-586f-e063-e6dba90add90Atenolol Tablets USP 25 mg, 50 mg and 100 mgRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-709-26Atenolol90 in 1 BOTTLE, PLASTICTABLET907
51655-709-52Atenolol30 in 1 BOTTLE, PLASTICTABLET307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-709ATENOLOL TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20250101_db5bd8e2-1314-0f7f-e053-2995a90ae86e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSNdb5bd8e2-1314-0f7f-e053-2995a90ae86e7
197380atenolol 25 MG Oral TabletSCDdb5bd8e2-1314-0f7f-e053-2995a90ae86e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-709-265165507092690 TABLET in 1 BOTTLE, PLASTIC (51655-709-26) 90 tablet2022-04-08NoNoCurrent
51655-709-525165507095230 TABLET in 1 BOTTLE, PLASTIC (51655-709-52) 30 tablet2021-05-07NoNoCurrent