FDA.reportPublic FDA data

Atenolol

Product NDC
21695-322
11-digit product format
216950322
Labeler code
21695
Product ID
21695-322_500ca21e-571b-4fa9-8b62-4914b226bf3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA077877
Marketing category
ANDA
Marketing start
1995-07-19
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
21695-322-302019-09-24C16284748780-1934fe258-4a6d-48b1-e053-8cdaa90a720aAtenolol 25 mg
21695-322-902019-09-24C16284748780-1934fe258-4a6d-48b1-e053-8cdaa90a720aAtenolol 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-322-30Atenolol30 in 1 BOTTLETABLET301
21695-322-90Atenolol90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-322-30EA - Each21695-322b508a5b9-db16-429d-9d63-0ed203380d1912012-07-24
21695-322-90EA - Each21695-3223b63a82c-65c4-4bfb-9c3d-a40bfa9e93eb12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-322ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 2 package rows20110706_500ca21e-571b-4fa9-8b62-4914b226bf3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSN500ca21e-571b-4fa9-8b62-4914b226bf3e1
197380atenolol 25 MG Oral TabletSCD500ca21e-571b-4fa9-8b62-4914b226bf3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-322-302169503223030 in 1 BOTTLEHistorical
21695-322-902169503229090 in 1 BOTTLEHistorical