Home NDC 43353-149 Atenolol and Chlorthalidone
Product NDC 43353-149
11-digit product format 433530149
Labeler code 43353
Product ID 43353-149_800910de-96de-4c4c-8028-221b98c7d164
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atenolol and Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA073665
Marketing category ANDA
Marketing start 1992-08-01
Marketing end 0000-00-00
Substance ATENOLOL; CHLORTHALIDONE
Active strength 50 mg/1; mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC],Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC exclude flag No
Listing certified through 2019-12-31
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 2 · 84 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A073665-001 ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 A073665-002 ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 88 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 2026-10-15 13:18:30 2026-09 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 43353-149-09 Atenolol and Chlorthalidone 9000 in 1 BOTTLE, PLASTIC TABLET 9000 1 43353-149-30 Atenolol and Chlorthalidone 30 in 1 BOTTLE, PLASTIC TABLET 30 1 43353-149-60 Atenolol and Chlorthalidone 90 in 1 BOTTLE, PLASTIC TABLET 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATENOLOL ACTIVE INGREDIENT 50VV3VW0TI ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CHLORTHALIDONE ACTIVE INGREDIENT Q0MQD1073Q ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ATENOLOL ACTIVE MOIETY 50VV3VW0TI ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CHLORTHALIDONE ACTIVE MOIETY Q0MQD1073Q ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-149 ATENOLOL AND CHLORTHALIDONE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Legacy NDC, 3 package rows 20140521_73705d59-49fa-4e5d-8e3b-13bc2ac8796b.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-149-09 43353014909 9000 in 1 BOTTLE, PLASTIC Historical 43353-149-30 43353014930 30 in 1 BOTTLE, PLASTIC Historical 43353-149-60 43353014960 90 in 1 BOTTLE, PLASTIC Historical