FDA.reportPublic FDA data

Atenolol

Product NDC
53808-0730
11-digit product format
538080730
Labeler code
53808
Product ID
53808-0730_81b9fca7-f47d-4293-87ae-856c4b1c5f96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA076900
Marketing category
ANDA
Marketing start
2009-07-01
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
E
Listing certified through
2017-12-31
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
53808-0730-12021-01-29C16284748780-1956f9ecf-c225-621f-e053-dbdaa90a74adAtenolol Tablets, USP
53808-0730-12019-10-21C16284748780-1956f9ecf-c225-621f-e053-dbdaa90a74adAtenolol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0730-1Atenolol30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0730ATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20100611_79000ef8-702c-47ec-aafc-9bc1dfd83e77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSN79000ef8-702c-47ec-aafc-9bc1dfd83e771
197380atenolol 25 MG Oral TabletPSN79000ef8-702c-47ec-aafc-9bc1dfd83e771
197381atenolol 50 MG Oral TabletPSN79000ef8-702c-47ec-aafc-9bc1dfd83e771
197379atenolol 100 MG Oral TabletSCD79000ef8-702c-47ec-aafc-9bc1dfd83e771
197380atenolol 25 MG Oral TabletSCD79000ef8-702c-47ec-aafc-9bc1dfd83e771
197381atenolol 50 MG Oral TabletSCD79000ef8-702c-47ec-aafc-9bc1dfd83e771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0730-15380807300130 in 1 BLISTER PACKHistorical