FDA.reportPublic FDA data

Atenolol

Product NDC
65841-022
11-digit product format
658410022
Labeler code
65841
Product ID
65841-022_f4fb6b85-6379-4e8a-9ee3-402819d128a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA076900
Marketing category
ANDA
Marketing start
2005-10-08
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
Rxcui197379, 197380, 197381

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-022-01Atenolol100 in 1 BOTTLETABLET10010
65841-022-10Atenolol1000 in 1 BOTTLETABLET100010
65841-022-16Atenolol90 in 1 BOTTLETABLET9010
65841-022-24Atenolol10000 in 1 BOTTLETABLET1000010
65841-022-40Atenolol5000 in 1 BOTTLETABLET500010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [CADILA HEALTHCARE LIMITED]3
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [CADILA HEALTHCARE LIMITED]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLATENOLOL TABLET [CADILA HEALTHCARE LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [CADILA HEALTHCARE LIMITED]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATENOLOL TABLET [CADILA HEALTHCARE LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [CADILA HEALTHCARE LIMITED]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EATENOLOL TABLET [CADILA HEALTHCARE LIMITED]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [CADILA HEALTHCARE LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-022ATENOLOL TABLET [ZYDUS LIFESCIENCES LIMITED]10Current NDC, Legacy NDC, 5 package rows20241128_2492d5f6-00b0-42c9-a793-2be83ea81ad1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSN2492d5f6-00b0-42c9-a793-2be83ea81ad110
197380atenolol 25 MG Oral TabletPSN2492d5f6-00b0-42c9-a793-2be83ea81ad110
197381atenolol 50 MG Oral TabletPSN2492d5f6-00b0-42c9-a793-2be83ea81ad110
197379atenolol 100 MG Oral TabletSCD2492d5f6-00b0-42c9-a793-2be83ea81ad110
197380atenolol 25 MG Oral TabletSCD2492d5f6-00b0-42c9-a793-2be83ea81ad110
197381atenolol 50 MG Oral TabletSCD2492d5f6-00b0-42c9-a793-2be83ea81ad110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-022-0165841002201100 TABLET in 1 BOTTLE (65841-022-01) 100 tablet2005-10-080000-00-00NoNoCurrent
65841-022-10658410022101000 TABLET in 1 BOTTLE (65841-022-10) 1000 tablet2005-10-080000-00-00NoNoCurrent
65841-022-166584100221690 TABLET in 1 BOTTLE (65841-022-16) 90 tablet2005-10-080000-00-00NoNoCurrent
65841-022-246584100222410000 TABLET in 1 BOTTLE (65841-022-24) 10000 tablet2005-10-080000-00-00NoNoCurrent
65841-022-40658410022405000 TABLET in 1 BOTTLE (65841-022-40) 5000 tablet2005-10-080000-00-00NoNoCurrent