Atenolol

Product NDC
55700-661
Requested package NDC
55700-661-30
11-digit product format
557000661
Labeler code
55700
Product ID
55700-661_dc52592d-0d7d-4815-8f3d-30b5ac4ed1c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA077443
Marketing category
ANDA
Marketing start
2018-07-26
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
100 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55700-66155700-661-30DDiscontinued 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
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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-661-30EA - Each55700-661c8c630dd-56e4-41f3-8c9b-3c63f7664d0612019-04-11
55700-661-90EA - Each55700-661f018895a-cd2c-4b6f-a6b9-1b4ffd1cd76f12018-09-05

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-661-305570006613030 TABLET in 1 BOTTLE (55700-661-30) 30 tablet2019-03-150000-00-00NoNoCurrent