Home NDC 10544-134 Atenolol
Product NDC 10544-134
11-digit product format 105440134
Labeler code 10544
Product ID 10544-134_101dd20f-f505-0837-e054-00144ff88e88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atenolol
Dosage form TABLET
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA077877
Marketing category ANDA
Marketing start 2013-09-03
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 E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 10544-134-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 10544-134-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 10544-134-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 10544-134-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 10544-134-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 10544-134-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 10544-134-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 10544-134-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 10544-134-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 10544-134-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 10544-134-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 10544-134-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 10544-134-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 10544-134-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 10544-134-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 10544-134-30 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 10544-134-30 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 10544-134-30 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 10544-134-30 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 10544-134-30 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 10544-134-30 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 10544-134-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077877-001 ATENOLOL ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 A077877-002 ATENOLOL ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 A077877-003 ATENOLOL ATENOLOL 100MG TABLET / ORAL AB 2006-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077877-001 ATENOLOL 25MG TABLET / ORAL 2006-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077877-002 ATENOLOL 50MG TABLET / ORAL 2006-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077877-003 ATENOLOL 100MG TABLET / ORAL 2006-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077877-001 ATENOLOL 25MG TABLET / ORAL 2006-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077877-002 ATENOLOL 50MG TABLET / ORAL 2006-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077877-003 ATENOLOL 100MG TABLET / ORAL 2006-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077877-001 ATENOLOL 25MG TABLET / ORAL 2006-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077877-002 ATENOLOL 50MG TABLET / ORAL 2006-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077877-003 ATENOLOL 100MG TABLET / ORAL 2006-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077877-001 ATENOLOL 25MG TABLET / ORAL 2006-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077877-002 ATENOLOL 50MG TABLET / ORAL 2006-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077877-003 ATENOLOL 100MG TABLET / ORAL 2006-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077877-001 ATENOLOL 25MG TABLET / ORAL 2006-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077877-002 ATENOLOL 50MG TABLET / ORAL 2006-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077877-003 ATENOLOL 100MG TABLET / ORAL 2006-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 108 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10544-134-30 Atenolol 30 in 1 BOTTLE TABLET 30 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATENOLOL ACTIVE INGREDIENT 50VV3VW0TI ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.] 4 ATENOLOL ACTIVE MOIETY 50VV3VW0TI ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.] 4 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.] 4 MAGNESIUM CARBONATE INACTIVE INGREDIENT 0E53J927NA ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.] 4 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-134 ATENOLOL TABLET [BLENHEIM PHARMACAL, INC.] 4 Legacy NDC, 1 package rows 20150228_2c34488c-e22b-46c6-80dd-b24c2bae8d7b.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Atenolol ATENOLOL Ipca Laboratories Limited 98d29958-b026-4888-a516-7bb85bb7d479 2026-01-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077877 application number: ANDA077877
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-134-30 10544013430 30 in 1 BOTTLE Historical