FDA.reportPublic FDA data

Atenolol

Product NDC
51655-736
11-digit product format
516550736
Labeler code
51655
Product ID
51655-736_4b998018-7463-b17e-e063-6394a90a0a61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA073457
Marketing category
ANDA
Marketing start
2021-06-17
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-736-262026-01-29C16284748780-149896155-abee-586f-e063-e6dba90add90d9cdc2ed-99bf-0d6a-e053-2a95a90a0262
51655-736-522026-01-29C16284748780-149896155-abee-586f-e063-e6dba90add90d9cdc2ed-99bf-0d6a-e053-2a95a90a0262

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-736-26Atenolol90 in 1 BOTTLE, PLASTICTABLET905
51655-736-52Atenolol30 in 1 BOTTLE, PLASTICTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-736ATENOLOL TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20241228_d9cdc2ed-99bf-0d6a-e053-2a95a90a0262.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSNd9cdc2ed-99bf-0d6a-e053-2a95a90a02625
197379atenolol 100 MG Oral TabletSCDd9cdc2ed-99bf-0d6a-e053-2a95a90a02625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-736-265165507362690 TABLET in 1 BOTTLE, PLASTIC (51655-736-26) 90 tablet2022-01-28NoNoHistorical
51655-736-525165507365230 TABLET in 1 BOTTLE, PLASTIC (51655-736-52) 30 tablet2021-06-17NoNoHistorical