Home NDC 67544-161-92 Atenolol
Product NDC 67544-161
Requested package NDC 67544-161-92
11-digit product format 675440161
Labeler code 67544
Product ID 67544-161_d38bdacd-b80a-4e86-b588-5a6eede1d075
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atenolol
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA074052
Marketing category ANDA
Marketing start 1992-05-01
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 No
Listing certified through 2020-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67544-161 67544-161-92 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 67544-161 67544-161-92 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog .
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.
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 2019-12-13 00:20 UTC 2019-12 A074052-001 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A074052-001 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074052-001 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074052-001 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 ea99ee380514…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67544-161 ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Legacy NDC 20190424_71adae77-b8f2-428f-9f56-3c334dffd048.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67544-161-92 67544016192 270 TABLET in 1 BOTTLE, PLASTIC (67544-161-92) 270 tablet 2011-10-24 0000-00-00 No No Current