Atenolol

Product NDC
68382-022
11-digit product format
683820022
Labeler code
68382
Product ID
68382-022_860eb406-b330-4b72-b768-122d57c74293
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
68382-022-01Atenolol100 in 1 BOTTLETABLET10013
68382-022-10Atenolol1000 in 1 BOTTLETABLET100013
68382-022-16Atenolol90 in 1 BOTTLETABLET9013
68382-022-24Atenolol10000 in 1 BOTTLETABLET1000013
68382-022-40Atenolol5000 in 1 BOTTLETABLET500013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-022-01EA - Each68382-022183e8e33-356d-4fa1-80b5-b09ee008fe3e12012-07-24
68382-022-10EA - Each68382-0228f3d5ea2-3e9b-476a-8a23-45c41e56af1812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]6
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLATENOLOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATENOLOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]6
POVIDONEINACTIVE INGREDIENTFZ989GH94EATENOLOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]6
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [BLENHEIM PHARMACAL, INC.]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLATENOLOL TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [BLENHEIM PHARMACAL, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EATENOLOL TABLET ATENOLOL ( ATENOLOL ) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EATENOLOL TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATENOLOL TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-022ATENOLOL TABLET [ZYDUS PHARMACEUTICALS USA INC.]13Current NDC, Legacy NDC, 5 package rows20240118_db801706-1362-44c7-92ab-f584f96c7e1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSN8acdb229-928b-4c22-88f1-f4dd97cde27421
197380atenolol 25 MG Oral TabletSCD8acdb229-928b-4c22-88f1-f4dd97cde27421
197379atenolol 100 MG Oral TabletPSNdb801706-1362-44c7-92ab-f584f96c7e1c13
197380atenolol 25 MG Oral TabletPSNdb801706-1362-44c7-92ab-f584f96c7e1c13
197381atenolol 50 MG Oral TabletPSNdb801706-1362-44c7-92ab-f584f96c7e1c13
197379atenolol 100 MG Oral TabletSCDdb801706-1362-44c7-92ab-f584f96c7e1c13
197380atenolol 25 MG Oral TabletSCDdb801706-1362-44c7-92ab-f584f96c7e1c13
197381atenolol 50 MG Oral TabletSCDdb801706-1362-44c7-92ab-f584f96c7e1c13
197379atenolol 100 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197379atenolol 100 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletPSNd19e9fcf-dfa1-43d7-94dc-e3f03fb90f5c4
197380atenolol 25 MG Oral TabletSCDd19e9fcf-dfa1-43d7-94dc-e3f03fb90f5c4
197380atenolol 25 MG Oral TabletPSN6a11aa30-15b0-3831-e053-2991aa0aba963
197380atenolol 25 MG Oral TabletSCD6a11aa30-15b0-3831-e053-2991aa0aba963
197380atenolol 25 MG Oral TabletPSN54b0cbf0-388b-6928-e054-00144ff8d46c2
197380atenolol 25 MG Oral TabletSCD54b0cbf0-388b-6928-e054-00144ff8d46c2
197379atenolol 100 MG Oral TabletPSN79000ef8-702c-47ec-aafc-9bc1dfd83e771
197380atenolol 25 MG Oral TabletPSNc16f2d09-e719-4846-94a6-d38ccdb8c9b11
197380atenolol 25 MG Oral TabletPSN79000ef8-702c-47ec-aafc-9bc1dfd83e771
197380atenolol 25 MG Oral TabletPSNeeb03292-9faf-4a20-a512-57e8850fe0fc1
197381atenolol 50 MG Oral TabletPSNc16f2d09-e719-4846-94a6-d38ccdb8c9b11
197381atenolol 50 MG Oral TabletPSN79000ef8-702c-47ec-aafc-9bc1dfd83e771
197379atenolol 100 MG Oral TabletSCD79000ef8-702c-47ec-aafc-9bc1dfd83e771
197380atenolol 25 MG Oral TabletSCDc16f2d09-e719-4846-94a6-d38ccdb8c9b11
197380atenolol 25 MG Oral TabletSCD79000ef8-702c-47ec-aafc-9bc1dfd83e771
197380atenolol 25 MG Oral TabletSCDeeb03292-9faf-4a20-a512-57e8850fe0fc1
197381atenolol 50 MG Oral TabletSCDc16f2d09-e719-4846-94a6-d38ccdb8c9b11
197381atenolol 50 MG Oral TabletSCD79000ef8-702c-47ec-aafc-9bc1dfd83e771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-022-0168382002201100 TABLET in 1 BOTTLE (68382-022-01) 100 tablet2005-10-080000-00-00NoNoCurrent
68382-022-10683820022101000 TABLET in 1 BOTTLE (68382-022-10) 1000 tablet2005-10-080000-00-00NoNoCurrent
68382-022-166838200221690 TABLET in 1 BOTTLE (68382-022-16) 90 tablet2005-10-080000-00-00NoNoCurrent
68382-022-246838200222410000 TABLET in 1 BOTTLE (68382-022-24) 10000 tablet2005-10-080000-00-00NoNoCurrent
68382-022-40683820022405000 TABLET in 1 BOTTLE (68382-022-40) 5000 tablet2005-10-080000-00-00NoNoCurrent