Atenolol

Product NDC
67544-240
11-digit product format
675440240
Labeler code
67544
Product ID
67544-240_b683fd4a-0b9c-4100-a6ff-73bc34b8e5d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA073457
Marketing category
ANDA
Marketing start
1999-06-17
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
25 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-240DDiscontinued by firm2026-08-03
excluded packagepackage67544-24067544-240-30DDiscontinued by firm2026-08-03
excluded packagepackage67544-24067544-240-45DDiscontinued by firm2026-08-03
excluded packagepackage67544-24067544-240-60DDiscontinued by firm2026-08-03
excluded packagepackage67544-24067544-240-80DDiscontinued by firm2026-08-03

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-240-30EA - Each67544-2400c497e1d-9e76-453b-a386-ed3a6d0b6c4012018-01-12
67544-240-45EA - Each67544-2403698e95d-d5cd-47aa-b139-8c9f7cb73deb12018-01-12
67544-240-60EA - Each67544-24060b952b1-09e5-449a-adf7-e8ee72b4a28012018-01-12
67544-240-80EA - Each67544-240c0751f3e-af50-45f4-a108-443e048c359d12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-240ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20171218_8e81d69a-e278-445a-ad36-9100a14eb470.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-240-306754402403030 TABLET in 1 BOTTLE, PLASTIC (67544-240-30) 30 tablet2015-05-120000-00-00NoNoCurrent
67544-240-456754402404545 TABLET in 1 BOTTLE, PLASTIC (67544-240-45) 45 tablet2014-11-130000-00-00NoNoCurrent
67544-240-606754402406090 TABLET in 1 BOTTLE, PLASTIC (67544-240-60) 90 tablet2015-02-110000-00-00NoNoCurrent
67544-240-8067544024080180 TABLET in 1 BOTTLE, PLASTIC (67544-240-80) 180 tablet2015-02-180000-00-00NoNoCurrent