FDA.reportPublic FDA data

Atenolol

Product NDC
0093-0787
11-digit product format
000930787
Labeler code
0093
Product ID
0093-0787_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
2004-11-16
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
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-0787-01Atenolol100 in 1 BOTTLETABLET10020
0093-0787-10Atenolol1000 in 1 BOTTLETABLET100020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0787-01EA - Each0093-07874357ddee-2729-41e3-9455-f35f86a4a3a112012-07-24
0093-0787-10EA - Each0093-07879b140f7a-4341-438c-a5cc-4aefa8d4874412012-07-24

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 [DIRECT RX]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [DIRECTRX]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [PROFICIENT RX LP]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [PROFICIENT RX LP]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [PROFICIENT RX LP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [DIRECT RX]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECTRX]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [PROFICIENT RX LP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [DIRECTRX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATENOLOL TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0787ATENOLOL 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
197380atenolol 25 MG Oral TabletPSN95761173-1c95-46b2-a08f-fbc3e70daba828
197380atenolol 25 MG Oral TabletSCD95761173-1c95-46b2-a08f-fbc3e70daba828
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
197380atenolol 25 MG Oral TabletPSN24f1f3f4-bbda-458b-b15f-d942c90534e26
197380atenolol 25 MG Oral TabletSCD24f1f3f4-bbda-458b-b15f-d942c90534e26
197379atenolol 100 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletPSN7366c6f8-4cb3-520e-e053-2991aa0a2cc85
197380atenolol 25 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197379atenolol 100 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletSCD7366c6f8-4cb3-520e-e053-2991aa0a2cc85
197380atenolol 25 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletPSN92bfe147-f86a-d0d2-e053-2a95a90a306f4
197380atenolol 25 MG Oral TabletPSN52a5d72e-a360-7259-e054-00144ff8d46c4
197380atenolol 25 MG Oral TabletPSN52a4945b-7346-484c-e054-00144ff88e884
197380atenolol 25 MG Oral TabletSCD52a5d72e-a360-7259-e054-00144ff8d46c4
197380atenolol 25 MG Oral TabletSCD92bfe147-f86a-d0d2-e053-2a95a90a306f4
197380atenolol 25 MG Oral TabletSCD52a4945b-7346-484c-e054-00144ff88e884
197380atenolol 25 MG Oral TabletPSN37264962-2415-3a7b-e054-00144ff8d46c2
197380atenolol 25 MG Oral TabletPSN23e96396-85d3-0d8e-e063-6394a90a614d2
197380atenolol 25 MG Oral TabletSCD23e96396-85d3-0d8e-e063-6394a90a614d2
197380atenolol 25 MG Oral TabletSCD37264962-2415-3a7b-e054-00144ff8d46c2
197380atenolol 25 MG Oral TabletPSNba0b0221-d4b3-4cb1-9435-53a75fcc4b401
197380atenolol 25 MG Oral TabletPSNc53a6028-840e-4e24-9c4e-d487782e0a201
197380atenolol 25 MG Oral TabletPSNd73a475a-c8c9-44a0-89ac-6a2d665c0d241
197380atenolol 25 MG Oral TabletPSNde7fdcec-f3be-4070-acad-727d3d9894ad1
197380atenolol 25 MG Oral TabletSCDba0b0221-d4b3-4cb1-9435-53a75fcc4b401
197380atenolol 25 MG Oral TabletSCDc53a6028-840e-4e24-9c4e-d487782e0a201
197380atenolol 25 MG Oral TabletSCDd73a475a-c8c9-44a0-89ac-6a2d665c0d241
197380atenolol 25 MG Oral TabletSCDde7fdcec-f3be-4070-acad-727d3d9894ad1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-0787-0100093078701100 TABLET in 1 BOTTLE (0093-0787-01) 100 tablet2004-11-160000-00-00NoNoCurrent
0093-0787-10000930787101000 TABLET in 1 BOTTLE (0093-0787-10) 1000 tablet2004-11-160000-00-00NoNoCurrent