Home NDC 68071-5162 Atenolol
Product NDC 68071-5162
11-digit product format 680715162
Labeler code 68071
Product ID 68071-5162_2ad2e8f8-6e33-182e-e063-6394a90a76c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atenolol
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA077443
Marketing category ANDA
Marketing start 2010-06-10
Substance ATENOLOL
Active strength 100 mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-5162-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-5162-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-5162-1 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A077443-001 ATENOLOL ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 A077443-002 ATENOLOL ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 A077443-003 ATENOLOL ATENOLOL 100MG TABLET / ORAL AB 2006-09-13
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 · 129 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 2026-09-14 22:38:34 2026-08 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077443-002 ATENOLOL 50MG TABLET / ORAL AB 2006-09-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077443-003 ATENOLOL 100MG TABLET / ORAL AB 2006-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077443-001 ATENOLOL 25MG TABLET / ORAL AB 2006-09-13 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Atenolol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATENOLOL 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 50VV3VW0TI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197379 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 68071-5162-1 Atenolol 100 in 1 BOTTLE TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-5162 ATENOLOL TABLET [NUCARE PHARMACEUTICALS,INC.] 4 Current NDC, Legacy NDC, 1 package rows 20250105_9db36b04-f353-55d6-e053-2a95a90ae08f.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 2 of 2 · 25 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Atenolol ATENOLOL NuCare Pharmaceuticals,Inc. 741f328d-21a1-3b19-e053-2a91aa0aa327 2024-06-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077443 application number: ANDA077443 Atenolol ATENOLOL NuCare Pharmaceuticals,Inc. 754a1ea1-1233-066f-e053-2991aa0a33a9 2024-06-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077443 application number: ANDA077443 Atenolol ATENOLOL NCS HealthCare of KY, LLC dba Vangard Labs c8cdb347-1767-4595-baff-b50987cd8c3a 2023-02-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077443 application number: ANDA077443 Atenolol ATENOLOL Proficient Rx LP 0a54656e-60dd-4ffc-b01a-423af19cd618 2022-07-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077443 application number: ANDA077443 Atenolol ATENOLOL Proficient Rx LP c3a23869-1e3f-40f0-9726-833700580113 2019-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077443 application number: ANDA077443
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-5162-1 68071516201 100 TABLET in 1 BOTTLE (68071-5162-1) 100 tablet 2020-02-03 0000-00-00 No No Current