Home NDC 71335-3178-5 Atenolol
Product NDC 71335-3178
Requested package NDC 71335-3178-5
11-digit product format 713353178
Labeler code 71335
Product ID 71335-3178_3aca509f-111d-4965-80f8-fefea17005b4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atenolol
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA077877
Marketing category ANDA
Marketing start 2007-12-04
Substance ATENOLOL
Active strength 100 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 45 .
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 · 135 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 2026-11-14 07:37:17 2026-10 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 d4dbc9d85df4…2026-11-14 07:37:17 2026-10 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 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 2027-12-31 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.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-3178-5 71335317805 20 TABLET in 1 BOTTLE (71335-3178-5) 20 tablet 2026-09-24 No No Current