FDA.reportPublic FDA data

Atenolol

Product NDC
0093-0752
11-digit product format
000930752
Labeler code
0093
Product ID
0093-0752_19103c06-1fed-45a4-a110-66465b4f2233
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074056
Marketing category
ANDA
Marketing start
1995-02-22
Substance
ATENOLOL
Active strength
50 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
ATENOLOL50 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
0093-0752-01Atenolol100 in 1 BOTTLETABLET10020
0093-0752-10Atenolol1000 in 1 BOTTLETABLET100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0752-01EA - Each0093-0752b2777b6c-5c7b-4ff2-a0ca-1f6b483ed1e012012-07-24
0093-0752-10EA - Each0093-07527129e7f4-55e9-43de-8f8b-e3f9f931519312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [TEVA PHARMACEUTICALS USA INC]11
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [TEVA PHARMACEUTICALS USA INC]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [TEVA PHARMACEUTICALS USA INC]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [TEVA PHARMACEUTICALS USA INC]11
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [TEVA PHARMACEUTICALS USA INC]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [TEVA PHARMACEUTICALS USA INC]11
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [DIRECTRX]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [MEDVANTX, INC.]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECTRX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECTRX]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [MEDVANTX, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0752ATENOLOL TABLET [TEVA PHARMACEUTICALS USA, INC.]20Current NDC, Legacy NDC, 2 package rows20250523_25a72ec9-de0f-44e5-90b8-da1aab0d3588.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSNc69b8e5e-c7c3-4883-9cea-f7f435a8ede826
197381atenolol 50 MG Oral TabletSCDc69b8e5e-c7c3-4883-9cea-f7f435a8ede826
197379atenolol 100 MG Oral TabletPSN25a72ec9-de0f-44e5-90b8-da1aab0d358820
197380atenolol 25 MG Oral TabletPSN25a72ec9-de0f-44e5-90b8-da1aab0d358820
197381atenolol 50 MG Oral TabletPSN25a72ec9-de0f-44e5-90b8-da1aab0d358820
197379atenolol 100 MG Oral TabletSCD25a72ec9-de0f-44e5-90b8-da1aab0d358820
197380atenolol 25 MG Oral TabletSCD25a72ec9-de0f-44e5-90b8-da1aab0d358820
197381atenolol 50 MG Oral TabletSCD25a72ec9-de0f-44e5-90b8-da1aab0d358820
197379atenolol 100 MG Oral TabletPSN616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197380atenolol 25 MG Oral TabletPSN616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197381atenolol 50 MG Oral TabletPSN616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197379atenolol 100 MG Oral TabletSCD616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197380atenolol 25 MG Oral TabletSCD616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197381atenolol 50 MG Oral TabletSCD616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197381atenolol 50 MG Oral TabletPSN991dd367-856a-411b-b80e-5b37b0536e7b8
197381atenolol 50 MG Oral TabletSCD991dd367-856a-411b-b80e-5b37b0536e7b8
197381atenolol 50 MG Oral TabletPSN70d7a585-7a46-4eac-b2b5-2ac5b98d98826
197381atenolol 50 MG Oral TabletSCD70d7a585-7a46-4eac-b2b5-2ac5b98d98826
197379atenolol 100 MG Oral TabletPSNb3821f11-a5e5-4868-b0f1-f51574d5dfaa4
197381atenolol 50 MG Oral TabletPSNb198b34c-861a-4b52-b4df-8c48b807520a4
197381atenolol 50 MG Oral TabletPSNb3821f11-a5e5-4868-b0f1-f51574d5dfaa4
197379atenolol 100 MG Oral TabletSCDb3821f11-a5e5-4868-b0f1-f51574d5dfaa4
197381atenolol 50 MG Oral TabletSCDb198b34c-861a-4b52-b4df-8c48b807520a4
197381atenolol 50 MG Oral TabletSCDb3821f11-a5e5-4868-b0f1-f51574d5dfaa4
197381atenolol 50 MG Oral TabletPSN4fbea9e7-60ba-1e82-e054-00144ff88e883
197381atenolol 50 MG Oral TabletSCD4fbea9e7-60ba-1e82-e054-00144ff88e883
197381atenolol 50 MG Oral TabletPSNc4e3ebde-1b80-4177-a6d8-fb0cab16613d1
197381atenolol 50 MG Oral TabletPSNc6bf064f-e5d9-42e3-b2e5-86ae3836d3571
197381atenolol 50 MG Oral TabletPSNf12b8144-3875-4192-b883-e89e256a89bb1
197381atenolol 50 MG Oral TabletPSN597aa208-96d1-285d-e053-2a91aa0a52491
197381atenolol 50 MG Oral TabletPSN28ea6fb6-11e5-4bfe-b169-41c8aeaab7051
197381atenolol 50 MG Oral TabletPSN247569d6-9a73-f1d0-e063-6394a90a667a1
197381atenolol 50 MG Oral TabletSCD597aa208-96d1-285d-e053-2a91aa0a52491
197381atenolol 50 MG Oral TabletSCDc4e3ebde-1b80-4177-a6d8-fb0cab16613d1
197381atenolol 50 MG Oral TabletSCD28ea6fb6-11e5-4bfe-b169-41c8aeaab7051
197381atenolol 50 MG Oral TabletSCDc6bf064f-e5d9-42e3-b2e5-86ae3836d3571
197381atenolol 50 MG Oral TabletSCDf12b8144-3875-4192-b883-e89e256a89bb1
197381atenolol 50 MG Oral TabletSCD247569d6-9a73-f1d0-e063-6394a90a667a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-0752-0100093075201100 TABLET in 1 BOTTLE (0093-0752-01) 100 tablet1995-02-220000-00-00NoNoCurrent
0093-0752-10000930752101000 TABLET in 1 BOTTLE (0093-0752-10) 1000 tablet1995-02-220000-00-00NoNoCurrent