FDA.reportPublic FDA data

Atenolol

Product NDC
29300-412
11-digit product format
293000412
Labeler code
29300
Product ID
29300-412_b84110b2-cefb-49d0-8b08-1057dbdc258b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA213136
Marketing category
ANDA
Marketing start
2019-11-21
Substance
ATENOLOL
Active strength
100 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
ATENOLOL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii50VV3VW0TI
Rxcui197379, 197380, 197381

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
29300-412-01Atenolol100 in 1 BOTTLETABLET1006
29300-412-05Atenolol500 in 1 BOTTLETABLET5006
29300-412-10Atenolol1000 in 1 BOTTLETABLET10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-412-10EA - Each29300-41263d1c38b-a1d5-4a09-ba32-fa203c90b4ba12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-412ATENOLOL TABLET [UNICHEM PHARMACEUTICALS (USA), INC.]6Current NDC, Legacy NDC, 3 package rows20240123_35d99c43-7305-4a4a-886e-a9bf3ee88fa8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSN35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197380atenolol 25 MG Oral TabletPSN35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197381atenolol 50 MG Oral TabletPSN35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197379atenolol 100 MG Oral TabletSCD35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197380atenolol 25 MG Oral TabletSCD35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197381atenolol 50 MG Oral TabletSCD35d99c43-7305-4a4a-886e-a9bf3ee88fa86
197379atenolol 100 MG Oral TabletPSNd7a93c64-0c52-4d72-a9be-37c7ca355cdf5
197379atenolol 100 MG Oral TabletSCDd7a93c64-0c52-4d72-a9be-37c7ca355cdf5
197379atenolol 100 MG Oral TabletPSN0ad0c7dd-e4e5-4968-9372-7a9bb30073ec1
197379atenolol 100 MG Oral TabletPSN290f4de3-8815-466c-81dc-8bc6323758961
197379atenolol 100 MG Oral TabletPSN2ee7b7da-303d-4a57-a1eb-25e8923660c01
197380atenolol 25 MG Oral TabletPSN2ee7b7da-303d-4a57-a1eb-25e8923660c01
197381atenolol 50 MG Oral TabletPSN2ee7b7da-303d-4a57-a1eb-25e8923660c01
197379atenolol 100 MG Oral TabletSCD0ad0c7dd-e4e5-4968-9372-7a9bb30073ec1
197379atenolol 100 MG Oral TabletSCD2ee7b7da-303d-4a57-a1eb-25e8923660c01
197379atenolol 100 MG Oral TabletSCD290f4de3-8815-466c-81dc-8bc6323758961
197380atenolol 25 MG Oral TabletSCD2ee7b7da-303d-4a57-a1eb-25e8923660c01
197381atenolol 50 MG Oral TabletSCD2ee7b7da-303d-4a57-a1eb-25e8923660c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29300-412-0129300041201100 TABLET in 1 BOTTLE (29300-412-01) 100 tablet2020-01-060000-00-00NoNoCurrent
29300-412-0529300041205500 TABLET in 1 BOTTLE (29300-412-05) 500 tablet2020-01-060000-00-00NoNoCurrent
29300-412-10293000412101000 TABLET in 1 BOTTLE (29300-412-10) 1000 tablet2022-08-260000-00-00NoNoCurrent