FDA.reportPublic FDA data

ATENOLOL

Product NDC
61919-914
11-digit product format
619190914
Labeler code
61919
Product ID
61919-914_87adb12d-96aa-535d-e053-2a95a90a17cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATENOLOL
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077877
Marketing category
ANDA
Marketing start
2017-11-10
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
61919-914-712024-01-30C16284748780-1ba0f9c33-4ef2-a910-e053-dadaa90a0b85ATENOLOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-914-71ATENOLOL100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-914-71EA - Each61919-914c5b77810-0d78-4b52-8372-c944017384c812017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [DIRECT RX]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATENOLOL TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-914ATENOLOL TABLET [DIRECT RX]5Legacy NDC, 1 package rows20190430_b002421f-8120-4e76-a9e2-cc356fbc4cff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197379atenolol 100 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-914-7161919091471100 TABLET in 1 BOTTLE (61919-914-71) 100 tablet2017-11-100000-00-00NoNoCurrent