FDA.reportPublic FDA data

Atenolol

Product NDC
70518-3036
11-digit product format
705183036
Labeler code
70518
Product ID
70518-3036_4b07663b-fc4b-4cad-e063-6294a90a1a8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078512
Marketing category
ANDA
Marketing start
2021-03-03
Substance
ATENOLOL
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atenolol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50VV3VW0TI
Rxcui197381

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
70518-3036-0Atenolol30 in 1 BLISTER PACKTABLET3010
70518-3036-1Atenolol90 in 1 BOTTLE, PLASTICTABLET9010
70518-3036-2Atenolol100 in 1 BOTTLE, PLASTICTABLET10010
70518-3036-3Atenolol30 in 1 BLISTER PACKTABLET3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3036ATENOLOL TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 4 package rows20250409_4ca8dd77-cdac-41fe-a742-b1b32551203b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSN4ca8dd77-cdac-41fe-a742-b1b32551203b10
197381atenolol 50 MG Oral TabletSCD4ca8dd77-cdac-41fe-a742-b1b32551203b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3036-07051830360030 TABLET in 1 BLISTER PACK (70518-3036-0) 30 tablet2021-03-030000-00-00NoNoCurrent
70518-3036-17051830360190 TABLET in 1 BOTTLE, PLASTIC (70518-3036-1) 90 tablet2021-03-120000-00-00NoNoCurrent
70518-3036-270518303602100 TABLET in 1 BOTTLE, PLASTIC (70518-3036-2) 100 tablet2021-06-160000-00-00NoNoCurrent
70518-3036-37051830360330 TABLET in 1 BLISTER PACK (70518-3036-3) 30 tablet2022-08-160000-00-00NoNoCurrent