Atenolol

Product NDC
0781-1507
Requested package NDC
0781-1507-10
11-digit product format
007811507
Labeler code
0781
Product ID
0781-1507_1e5460cc-8e8d-44cf-b14b-7129a0e95122
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA073026
Marketing category
ANDA
Marketing start
1991-09-17
Marketing end
2021-12-31
Substance
ATENOLOL
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0781-15070781-1507-10DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
A073026-001ATENOLOLATENOLOL100MGTABLET / ORALAB1991-09-17
A073026-002ATENOLOLATENOLOL25MGTABLET / ORALAB1992-05-01
A073026-003ATENOLOLATENOLOL50MGTABLET / ORALAB1991-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A073026-001AB
A073026-002AB
A073026-003AB

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 3 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073026-002ATENOLOL25MGTABLET / ORALAB1992-05-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073026-003ATENOLOL50MGTABLET / ORALAB1991-09-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073026-001ATENOLOL100MGTABLET / ORALAB1991-09-178072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 115 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A073026-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073026-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073026-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073026-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073026-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073026-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073026-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073026-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073026-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073026-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073026-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073026-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073026-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073026-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073026-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073026-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073026-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073026-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073026-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073026-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073026-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073026-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073026-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073026-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073026-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073026-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073026-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073026-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073026-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073026-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073026-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073026-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073026-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073026-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073026-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073026-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073026-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073026-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073026-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073026-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1507-01EA - Each0781-1507b73e0197-6eb1-4efd-b913-f774e4c2e08712012-07-24
0781-1507-10EA - Each0781-1507cf901eae-9a14-4460-87eb-e0c48cde293712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [SANDOZ INC]15
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [SANDOZ INC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [SANDOZ INC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [SANDOZ INC]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [SANDOZ INC]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [SANDOZ INC]15
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [REDPHARM DRUG INC.]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [REDPHARM DRUG INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [REDPHARM DRUG INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [REDPHARM DRUG INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [REDPHARM DRUG INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [REDPHARM DRUG INC.]1

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLBryant Ranch Prepack1ec7b937-e448-45c7-ad7a-55fd722a50a62024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073026
application number: ANDA073026
AtenololATENOLOLBryant Ranch Prepackecfcebcc-8fcd-48e6-871e-151074df3abc2024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073026
application number: ANDA073026
AtenololATENOLOLBryant Ranch Prepack79490e9f-bbed-4e8f-b640-7d218741303a2024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073026
application number: ANDA073026

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSNe6611d33-f4c7-40c4-8db8-6f43c85d444c11
197381atenolol 50 MG Oral TabletPSNe6611d33-f4c7-40c4-8db8-6f43c85d444c11
197379atenolol 100 MG Oral TabletSCDe6611d33-f4c7-40c4-8db8-6f43c85d444c11
197381atenolol 50 MG Oral TabletSCDe6611d33-f4c7-40c4-8db8-6f43c85d444c11
197379atenolol 100 MG Oral TabletPSNdc429f91-5de5-4a4a-9943-422ec23316941
197379atenolol 100 MG Oral TabletSCDdc429f91-5de5-4a4a-9943-422ec23316941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-1507-10007811507101000 TABLET in 1 BOTTLE (0781-1507-10) 1000 tablet1991-09-172021-10-31NoNoCurrent