FDA.reportPublic FDA data

Atenolol

Product NDC
51079-684
11-digit product format
510790684
Labeler code
51079
Product ID
51079-684_3a398220-780d-f6f3-e063-6294a90a0210
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA073457
Marketing category
ANDA
Marketing start
1997-07-24
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
51079-684-01Atenolol1 in 1 BLISTER PACKTABLET125
51079-684-20Atenolol100 in 1 CARTONTABLET10025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-684-01EA - Each51079-684fbcdc1cb-d9e0-478a-89e3-39ba9ed0485712012-07-24
51079-684-17EA - Each51079-684b044ac2e-4415-4fab-8f11-9f3b51f1306a12012-07-24
51079-684-19EA - Each51079-6840efe1be0-8f07-4309-8f0a-e6f32c02a2aa12012-07-24
51079-684-20EA - Each51079-684962eeab3-61e7-4ee9-9e19-5ec4e5c467ec12012-07-24
51079-684-63EA - Each51079-68474faa89e-236c-492e-85d0-f8915e02be6412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [CARDINAL HEALTH]7
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [CARDINAL HEALTH]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [CARDINAL HEALTH]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [CARDINAL HEALTH]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [CARDINAL HEALTH]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [CARDINAL HEALTH]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [CARDINAL HEALTH]7
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [MYLAN INSTITUTIONAL INC.]4
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [MYLAN INSTITUTIONAL INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [MYLAN INSTITUTIONAL INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [MYLAN INSTITUTIONAL INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [MYLAN INSTITUTIONAL INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [MYLAN INSTITUTIONAL INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-684ATENOLOL TABLET [MYLAN INSTITUTIONAL INC.]24Current NDC, Legacy NDC, 2 package rows20250413_8dd93a47-d14c-49be-9c22-97c0cdbec75a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSN8dd93a47-d14c-49be-9c22-97c0cdbec75a25
197380atenolol 25 MG Oral TabletPSN8dd93a47-d14c-49be-9c22-97c0cdbec75a25
197381atenolol 50 MG Oral TabletPSN8dd93a47-d14c-49be-9c22-97c0cdbec75a25
197379atenolol 100 MG Oral TabletSCD8dd93a47-d14c-49be-9c22-97c0cdbec75a25
197380atenolol 25 MG Oral TabletSCD8dd93a47-d14c-49be-9c22-97c0cdbec75a25
197381atenolol 50 MG Oral TabletSCD8dd93a47-d14c-49be-9c22-97c0cdbec75a25
197380atenolol 25 MG Oral TabletPSN15c0c2df-f195-45f9-a1e4-1ed2a43c221622
197381atenolol 50 MG Oral TabletPSN15c0c2df-f195-45f9-a1e4-1ed2a43c221622
197380atenolol 25 MG Oral TabletSCD15c0c2df-f195-45f9-a1e4-1ed2a43c221622
197381atenolol 50 MG Oral TabletSCD15c0c2df-f195-45f9-a1e4-1ed2a43c221622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-684-01510790684011 in 1 BLISTER PACKHistorical
51079-684-2051079068420100 BLISTER PACK in 1 CARTON (51079-684-20) / 1 TABLET in 1 BLISTER PACK (51079-684-01) 100 blister pack1997-07-240000-00-00NoNoCurrent