Home NDC 75834-283 Atenolol
Product NDC 75834-283
11-digit product format 758340283
Labeler code 75834
Product ID 75834-283_af3cca55-4c04-4381-9827-20016b2e4bef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atenolol
Dosage form TABLET
Route ORAL
Labeler Nivagen Pharmaceuticals, Inc.
Application ANDA073026
Marketing category ANDA
Marketing start 2022-12-19
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 2023-12-31
Current FDA listing Historical FDA.report record 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 A073026-001 ATENOLOL ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 A073026-002 ATENOLOL ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 A073026-003 ATENOLOL ATENOLOL 50MG TABLET / ORAL AB 1991-09-17
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 3 · 115 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 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073026-002 ATENOLOL 25MG TABLET / ORAL AB 1992-05-01 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073026-003 ATENOLOL 50MG TABLET / ORAL AB 1991-09-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073026-001 ATENOLOL 100MG TABLET / ORAL AB 1991-09-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 115 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 75834-283-00 Atenolol 1000 in 1 BOTTLE TABLET 1000 2 75834-283-01 Atenolol 100 in 1 BOTTLE TABLET 100 2 75834-283-10 Atenolol 1 in 1 DRUM TABLET 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75834-283 ATENOLOL TABLET [NIVAGEN PHARMACEUTICALS, INC.] 2 Legacy NDC, 2 package rows 20240210_af3cca55-4c04-4381-9827-20016b2e4bef.zip 75834-283 ATENOLOL TABLET [NIVAGEN PHARMACEUTICALS, INC.] 1 Legacy NDC, 1 package rows 20240724_bc9b6990-4e55-4c6e-ab61-fdb207b15df5.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 · 3 matching rows.
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 75834-283-00 75834028300 1000 TABLET in 1 BOTTLE (75834-283-00) 1000 tablet 2022-12-19 0000-00-00 No No Current 75834-283-01 75834028301 100 TABLET in 1 BOTTLE (75834-283-01) 100 tablet 2022-12-19 0000-00-00 No No Current 75834-283-10 75834028310 1 in 1 DRUM Historical