Atenolol

Product NDC
68788-7616
11-digit product format
687887616
Labeler code
68788
Product ID
68788-7616_8144c92d-a041-42b8-949f-b7949f91bccf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA077443
Marketing category
ANDA
Marketing start
2020-02-07
Substance
ATENOLOL
Active strength
50 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
A077443-001ATENOLOLATENOLOL25MGTABLET / ORALAB2006-09-13
A077443-002ATENOLOLATENOLOL50MGTABLET / ORALAB2006-09-13
A077443-003ATENOLOLATENOLOL100MGTABLET / ORALAB2006-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077443-001AB
A077443-002AB
A077443-003AB

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 UTC2026-02A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-138072bd15b7f6…

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 UTC2026-02A077443-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077443-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077443-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077443-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL50 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
a8d48a47-ccab-4a35-a092-6e562683ade3Available 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
68788-7616-1Atenolol100 in 1 BOTTLETABLET1007
68788-7616-3Atenolol30 in 1 BOTTLETABLET307
68788-7616-6Atenolol60 in 1 BOTTLETABLET607
68788-7616-9Atenolol90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7616-1EA - Each68788-761622659719-99f7-48cd-8e9a-08c2d52bde7712020-03-10
68788-7616-3EA - Each68788-7616d11b4f34-910d-4efe-a170-316f0e3817e512020-03-10
68788-7616-6EA - Each68788-7616d537b6b4-0fcc-4399-a65a-0cd78f7ab21f12020-03-10
68788-7616-9EA - Each68788-7616f86e8668-58d7-4f4d-81e9-ee9361752ad012020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7616ATENOLOL TABLET [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 package rows20250206_a8d48a47-ccab-4a35-a092-6e562683ade3.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLSt. Mary's Medical Park Pharmacy7f8304a4-93de-774f-e053-2a91aa0aa5b52026-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLSt Mary's Medical Park Pharmacy78d394b8-8ffb-a846-e053-2991aa0aa58c2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLSt. Mary's Medical Park Pharmacy8501f6c1-8157-4189-e053-2a91aa0ac4ef2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLPreferred Pharmaceuticals, Inc.26d3df38-20c6-40e0-a456-da4f10fff6322026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLPreferred Pharmaceuticals, Inc.a8d48a47-ccab-4a35-a092-6e562683ade32026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
ndc (product): 68788-7616
AtenololATENOLOLPreferred Pharmaceuticals Inc.82100fc8-5a5a-4d80-8101-72024ee0abef2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
atenololATENOLOLdirect rxb3c757de-1cbf-61f5-e053-2995a90accfc2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLA-S Medication Solutions43acd912-f0f4-47eb-b81f-cbbfed77c5572026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLA-S Medication Solutionse4ece8f4-3714-42ba-b36d-d00586dfd33a2026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNorthwind Health Company, LLCdb5bd8e2-1314-0f7f-e053-2995a90ae86e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLQPharma, Inc.bd43e0b1-c05e-01ae-e053-2a95a90af1cd2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLRising Pharma Holdings, Inc.96dd038f-b363-4e24-9c67-82b7c85c3bc42025-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNuCare Pharmaceuticals,Inc.8115a2bc-69aa-60b4-e053-2a91aa0aeae72025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLDirect_Rxee143f2f-be60-bc67-e053-2a95a90ae6e62025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
ATENOLOLATENOLOLdirect rxb3d9f826-7ed7-1e3b-e053-2995a90ae7312025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNuCare Pharmaceuticals,Inc.9db36b04-f353-55d6-e053-2a95a90ae08f2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLBryant Ranch Prepack722d6532-20d0-4936-ae9c-b7bb593b960a2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLBryant Ranch Prepackc7a8830a-5eda-4f0e-bf03-61ee8ed6558d2024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLBryant Ranch Prepack1d6ea66b-30ef-4829-b757-5ea9d412a6662024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNuCare Pharmaceuticals,Inc.73671d55-3e10-cb1d-e053-2991aa0ac0382024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197381atenolol 50 MG Oral TabletPSNa8d48a47-ccab-4a35-a092-6e562683ade37
197381atenolol 50 MG Oral TabletSCDa8d48a47-ccab-4a35-a092-6e562683ade37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7616-168788761601100 TABLET in 1 BOTTLE (68788-7616-1) 100 tablet2020-02-070000-00-00NoNoCurrent
68788-7616-36878876160330 TABLET in 1 BOTTLE (68788-7616-3) 30 tablet2020-02-070000-00-00NoNoCurrent
68788-7616-66878876160660 TABLET in 1 BOTTLE (68788-7616-6) 60 tablet2020-02-070000-00-00NoNoCurrent
68788-7616-96878876160990 TABLET in 1 BOTTLE (68788-7616-9) 90 tablet2020-02-070000-00-00NoNoCurrent