FDA.reportPublic FDA data

Atenolol

Product NDC
63187-537
11-digit product format
631870537
Labeler code
63187
Product ID
63187-537_68da0b58-ba04-4184-bb85-52c3d9137f5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074056
Marketing category
ANDA
Marketing start
2004-11-16
Substance
ATENOLOL
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atenolol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50VV3VW0TI
Rxcui197380

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-537-10Atenolol10 in 1 BOTTLETABLET106
63187-537-30Atenolol30 in 1 BOTTLETABLET306
63187-537-60Atenolol60 in 1 BOTTLETABLET606
63187-537-90Atenolol90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-537-10EA - Each63187-537c6a1c90e-7478-4c8b-91f1-db87a40aff8612016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [PROFICIENT RX LP]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [PROFICIENT RX LP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-537ATENOLOL TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20220702_24f1f3f4-bbda-458b-b15f-d942c90534e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSN24f1f3f4-bbda-458b-b15f-d942c90534e26
197380atenolol 25 MG Oral TabletSCD24f1f3f4-bbda-458b-b15f-d942c90534e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-537-106318705371010 TABLET in 1 BOTTLE (63187-537-10) 10 tablet2016-09-010000-00-00NoNoCurrent
63187-537-306318705373030 TABLET in 1 BOTTLE (63187-537-30) 30 tablet2015-01-010000-00-00NoNoCurrent
63187-537-606318705376060 TABLET in 1 BOTTLE (63187-537-60) 60 tablet2015-01-010000-00-00NoNoCurrent
63187-537-906318705379090 TABLET in 1 BOTTLE (63187-537-90) 90 tablet2016-01-010000-00-00NoNoCurrent