FDA.reportPublic FDA data

Atenolol

Product NDC
71610-658
11-digit product format
716100658
Labeler code
71610
Product ID
71610-658_24bc1717-1cba-4452-a2db-f53e513329b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA073457
Marketing category
ANDA
Marketing start
1999-04-26
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
71610-658-30Atenolol30 in 1 BOTTLE, PLASTICTABLET302
71610-658-45Atenolol45 in 1 BOTTLE, PLASTICTABLET452
71610-658-60Atenolol90 in 1 BOTTLE, PLASTICTABLET902
71610-658-80Atenolol180 in 1 BOTTLE, PLASTICTABLET1802
71610-658-92Atenolol270 in 1 BOTTLE, PLASTICTABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-658-30EA - Each71610-65808bf6144-e131-43c9-9b00-beb73fefd85912022-10-06
71610-658-45EA - Each71610-6584ff0a40d-0bf3-4520-97ab-4e3c6b2fe5de12022-10-06
71610-658-60EA - Each71610-658061d4a20-f263-4c05-bc03-b951877ce60f12022-10-06
71610-658-80EA - Each71610-658b828a37c-2054-419c-b925-1ade4f1b4e9d12022-10-06
71610-658-92EA - Each71610-658d685b5ae-dc6c-43e6-be6b-3fc0ce9b292c12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-658ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, Legacy NDC, 5 package rows20220825_9aef7a49-d21f-4529-8abf-68bdc343bb6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSN9aef7a49-d21f-4529-8abf-68bdc343bb6c2
197380atenolol 25 MG Oral TabletSCD9aef7a49-d21f-4529-8abf-68bdc343bb6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-658-307161006583030 TABLET in 1 BOTTLE, PLASTIC (71610-658-30) 30 tablet2022-08-240000-00-00NoNoCurrent
71610-658-457161006584545 TABLET in 1 BOTTLE, PLASTIC (71610-658-45) 45 tablet2022-08-120000-00-00NoNoCurrent
71610-658-607161006586090 TABLET in 1 BOTTLE, PLASTIC (71610-658-60) 90 tablet2022-08-240000-00-00NoNoCurrent
71610-658-8071610065880180 TABLET in 1 BOTTLE, PLASTIC (71610-658-80) 180 tablet2022-08-120000-00-00NoNoCurrent
71610-658-9271610065892270 TABLET in 1 BOTTLE, PLASTIC (71610-658-92) 270 tablet2022-08-240000-00-00NoNoCurrent