Home NDC 0591-5783 Atenolol and Chlorthalidone
Product NDC 0591-5783
11-digit product format 005915783
Labeler code 0591
Product ID 0591-5783_b15eb43d-d93a-4e5f-b113-bc256779a40d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atenolol and Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA073665
Marketing category ANDA
Marketing start 1992-08-01
Substance ATENOLOL; CHLORTHALIDONE
Active strength 100; 25 mg/1; mg/1
Pharmacologic classes Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide-like Diuretic [EPC], beta-Adrenergic Blocker [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 3 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0591-5783 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 0591-5783 0591-5783-00 UNFINISHED Active or certified unfinished drug listing 2026-08-03 unfinished package package 0591-5783 0591-5783-77 UNFINISHED Active or certified unfinished drug listing 2026-08-03
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 · 54 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 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…2019-12-13 00:20 UTC 2019-12 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073665-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 1992-07-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A073665-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 1992-07-02 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Atenolol and Chlorthalidone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATENOLOL 100 mg/1 CHLORTHALIDONE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Q0MQD1073Q Internal UNII lookup 50VV3VW0TI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197382 Internal RxNorm lookup 197383 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-5783-01 Atenolol and Chlorthalidone 100 in 1 BOTTLE TABLET 100 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATENOLOL ACTIVE INGREDIENT 50VV3VW0TI ATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.] 9 CHLORTHALIDONE ACTIVE INGREDIENT Q0MQD1073Q ATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.] 9 ATENOLOL ACTIVE MOIETY 50VV3VW0TI ATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.] 9 CHLORTHALIDONE ACTIVE MOIETY Q0MQD1073Q ATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.] 9 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.] 9 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ ATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.] 9 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATENOLOL AND CHLORTHALIDONE TABLET [WATSON LABORATORIES, INC.] 9 ATENOLOL ACTIVE INGREDIENT 50VV3VW0TI ATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 ATENOLOL ACTIVE INGREDIENT 50VV3VW0TI ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.] 1 CHLORTHALIDONE ACTIVE INGREDIENT Q0MQD1073Q ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.] 1 CHLORTHALIDONE ACTIVE INGREDIENT Q0MQD1073Q ATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 ATENOLOL ACTIVE MOIETY 50VV3VW0TI ATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 ATENOLOL ACTIVE MOIETY 50VV3VW0TI ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.] 1 CHLORTHALIDONE ACTIVE MOIETY Q0MQD1073Q ATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CHLORTHALIDONE ACTIVE MOIETY Q0MQD1073Q ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E ATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATENOLOL AND CHLORTHALIDONE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATENOLOL AND CHLORTHALIDONE TABLET [REBEL DISTRIBUTORS CORP.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-5783 ATENOLOL AND CHLORTHALIDONE TABLET [ACTAVIS PHARMA, INC.] 17 Current NDC, Legacy NDC, 1 package rows 20250417_a6794dfa-adbb-491b-9d48-f89a44e866c5.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 Units Marketing start Marketing end Sample Exclude flag Status 0591-5783-00 00591578300 37740 TABLET in 1 BOX (0591-5783-00) 37740 tablet 01-AUG-92 Current 0591-5783-01 00591578301 100 TABLET in 1 BOTTLE (0591-5783-01) 100 tablet 1992-08-01 0000-00-00 No No Current 0591-5783-77 00591578377 45288 TABLET in 1 CARTON (0591-5783-77) 45288 tablet 04-JUL-24 Current