Atenolol

Product NDC
55154-5511
11-digit product format
551545511
Labeler code
55154
Product ID
55154-5511_04842f58-4db4-487d-a5b2-2c9aed6eceeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA073457
Marketing category
ANDA
Marketing start
2011-06-20
Substance
ATENOLOL
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A073457-001ATENOLOLATENOLOL100MGTABLET / ORALAB1992-01-24
A073457-002ATENOLOLATENOLOL25MGTABLET / ORALAB1999-04-26
A073457-003ATENOLOLATENOLOL50MGTABLET / ORALAB1992-01-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A073457-001AB
A073457-002AB
A073457-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A073457-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073457-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073457-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073457-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073457-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073457-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073457-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073457-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073457-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073457-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Atenolol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50VV3VW0TIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197380Internal RxNorm lookup
197381Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15c0c2df-f195-45f9-a1e4-1ed2a43c2216Available on FDA.report

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
55154-5511-0Atenolol1 in 1 BLISTER PACKTABLET122
55154-5511-0Atenolol10 in 1 BAGTABLET1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-5511-0EA - Each55154-551117ba8b64-1a0e-4d41-ab29-59f3041a2bd212020-03-10

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5511ATENOLOL TABLET [CARDINAL HEALTH 107, LLC]20Current NDC, Legacy NDC, 2 package rows20240316_15c0c2df-f195-45f9-a1e4-1ed2a43c2216.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLCardinal Health 107, LLC0fadc652-b075-46ec-ae05-beaf7d91ae132026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLSafecor Health, LLC35d04cfd-34d4-429c-b990-a6c00137bc772026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLGolden State Medical Supply, Inc.f4f06c00-9024-4e04-a882-0da2b24d8ff72026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLCardinal Health 107, LLC15c0c2df-f195-45f9-a1e4-1ed2a43c22162026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
ndc (product): 55154-5511
AtenololATENOLOLMylan Pharmaceuticals Inc.a7048c81-6769-436b-8397-fbaa7489fcdf2026-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLNorthwind Health Company, LLCf318707a-4fb9-604c-e053-2a95a90ae9732026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLNorthwind Health Company, LLCd9cdc2ed-99bf-0d6a-e053-2a95a90a02622026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLMylan Institutional Inc.8dd93a47-d14c-49be-9c22-97c0cdbec75a2025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
ATENOLOLATENOLOLdirect rxb3d9f826-7ed7-1e3b-e053-2995a90ae7312025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC9aef7a49-d21f-4529-8abf-68bdc343bb6c2022-08-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLProficient Rx LPe115f27a-6a7c-498c-b4a1-2d4c5716af222020-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLCb02b4be4-b75c-4153-b402-cf330a0774392017-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
55154-5511-05515455110010 BLISTER PACK in 1 BAG (55154-5511-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2011-06-200000-00-00NoNoCurrent