FDA.reportPublic FDA data

Atenolol

Product NDC
64980-439
11-digit product format
649800439
Labeler code
64980
Product ID
64980-439_7bf7d854-7736-4159-81e0-2f9f0c12d73c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA077443
Marketing category
ANDA
Marketing start
2010-06-10
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
64980-439-01Atenolol100 in 1 BOTTLETABLET1005
64980-439-10Atenolol1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-439-01EA - Each64980-439d6e8afbd-d3ce-48a2-897a-77842e5a4fae12018-02-20
64980-439-10EA - Each64980-439b148e6de-12af-4883-b35a-8628eda0e93612018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [DIRECT RX]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [DIRECT RX]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
64980-439ATENOLOL TABLET [RISING PHARMA HOLDINGS, INC.]4Current NDC, Legacy NDC, 2 package rows20240529_96dd038f-b363-4e24-9c67-82b7c85c3bc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSN1d6ea66b-30ef-4829-b757-5ea9d412a666104
197379atenolol 100 MG Oral TabletSCD1d6ea66b-30ef-4829-b757-5ea9d412a666104
197379atenolol 100 MG Oral TabletPSN26d3df38-20c6-40e0-a456-da4f10fff6328
197379atenolol 100 MG Oral TabletSCD26d3df38-20c6-40e0-a456-da4f10fff6328
197379atenolol 100 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197379atenolol 100 MG Oral TabletPSN96dd038f-b363-4e24-9c67-82b7c85c3bc45
197379atenolol 100 MG Oral TabletPSN8115a2bc-69aa-60b4-e053-2a91aa0aeae75
197380atenolol 25 MG Oral TabletPSN96dd038f-b363-4e24-9c67-82b7c85c3bc45
197380atenolol 25 MG Oral TabletPSNb002421f-8120-4e76-a9e2-cc356fbc4cff5
197381atenolol 50 MG Oral TabletPSN96dd038f-b363-4e24-9c67-82b7c85c3bc45
197379atenolol 100 MG Oral TabletSCD8115a2bc-69aa-60b4-e053-2a91aa0aeae75
197379atenolol 100 MG Oral TabletSCD96dd038f-b363-4e24-9c67-82b7c85c3bc45
197379atenolol 100 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5
197380atenolol 25 MG Oral TabletSCD96dd038f-b363-4e24-9c67-82b7c85c3bc45
197380atenolol 25 MG Oral TabletSCDb002421f-8120-4e76-a9e2-cc356fbc4cff5
197381atenolol 50 MG Oral TabletSCD96dd038f-b363-4e24-9c67-82b7c85c3bc45
197379atenolol 100 MG Oral TabletPSN9db36b04-f353-55d6-e053-2a95a90ae08f4
197379atenolol 100 MG Oral TabletSCD9db36b04-f353-55d6-e053-2a95a90ae08f4
197379atenolol 100 MG Oral TabletPSNb3c757de-1cbf-61f5-e053-2995a90accfc3
197379atenolol 100 MG Oral TabletPSN3b74864b-d055-4ab6-8e0f-aed17e3b05823
197379atenolol 100 MG Oral TabletPSN78d394b8-8ffb-a846-e053-2991aa0aa58c3
197379atenolol 100 MG Oral TabletSCD3b74864b-d055-4ab6-8e0f-aed17e3b05823
197379atenolol 100 MG Oral TabletSCD78d394b8-8ffb-a846-e053-2991aa0aa58c3
197379atenolol 100 MG Oral TabletSCDb3c757de-1cbf-61f5-e053-2995a90accfc3
197379atenolol 100 MG Oral TabletPSN92319404-c8af-45cd-b768-b62ca8204ba01
197379atenolol 100 MG Oral TabletSCD92319404-c8af-45cd-b768-b62ca8204ba01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-439-0164980043901100 TABLET in 1 BOTTLE (64980-439-01) 100 tablet2010-06-100000-00-00NoNoCurrent
64980-439-10649800439101000 TABLET in 1 BOTTLE (64980-439-10) 1000 tablet2010-06-100000-00-00NoNoCurrent