FDA.reportPublic FDA data

ATENOLOL

Product NDC
61919-279
11-digit product format
619190279
Labeler code
61919
Product ID
61919-279_b1926c63-b001-e7b9-e053-2a95a90ac8ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATENOLOL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA074056
Marketing category
ANDA
Marketing start
2019-09-17
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
2023-12-31
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
61919-279-902024-01-30C16284748780-1ba0f9c33-4ef2-a910-e053-dadaa90a0b85ATENOLOL
61919-279-902021-01-29C16284748780-1ba0f9c33-4ef2-a910-e053-dadaa90a0b85ATENOLOL
61919-279-602020-01-31C16284748780-19d75b9d0-4e58-f424-e053-dadaa90a57ceATENOLOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-279-90ATENOLOL90 in 1 BOTTLETABLET905
61919-279-30ATENOLOL30 in 1 BOTTLETABLET304
61919-279-60ATENOLOL60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-279-30EA - Each61919-279f35df2a8-2281-4435-bc0f-d07c4861b99c12019-10-07
61919-279-60EA - Each61919-279b5d95c89-c3b3-4564-ba04-aca491a78abe12019-09-05
61919-279-90EA - Each61919-2790a665882-63df-4c0a-9ff4-7dbf68e2e1f912019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [DIRECTRX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [DIRECTRX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [DIRECT RX]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECTRX]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [DIRECTRX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATENOLOL TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-279ATENOLOL TABLET [DIRECT RX]5Legacy NDC, 1 package rows20190430_b002421f-8120-4e76-a9e2-cc356fbc4cff.zip
61919-279ATENOLOL TABLET [DIRECT_RX]4Legacy NDC, 1 package rows20240110_92bfe147-f86a-d0d2-e053-2a95a90a306f.zip
61919-279ATENOLOL TABLET [DIRECTRX]1Legacy NDC, 1 package rows20151030_de7fdcec-f3be-4070-acad-727d3d9894ad.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
197380atenolol 25 MG Oral TabletPSN92bfe147-f86a-d0d2-e053-2a95a90a306f4
197380atenolol 25 MG Oral TabletSCD92bfe147-f86a-d0d2-e053-2a95a90a306f4
197380atenolol 25 MG Oral TabletPSNde7fdcec-f3be-4070-acad-727d3d9894ad1
197380atenolol 25 MG Oral TabletSCDde7fdcec-f3be-4070-acad-727d3d9894ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-279-306191902793030 TABLET in 1 BOTTLE (61919-279-30) 30 tablet2019-09-170000-00-00NoNoCurrent
61919-279-606191902796060 in 1 BOTTLEHistorical
61919-279-906191902799090 in 1 BOTTLEHistorical