Home NDC 70518-4111 Atenolol and Chlorthalidone
Product NDC 70518-4111
11-digit product format 705184111
Labeler code 70518
Product ID 70518-4111_5a096846-d052-28cd-e063-6294a90a1f46
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atenolol and Chlorthalidone
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA213302
Marketing category ANDA
Marketing start 2024-06-25
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A213302-001 ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 A213302-002 ATENOLOL AND CHLORTHALIDONE ATENOLOL; CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB RS 2020-11-25
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 2 · 76 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 2026-09-14 22:38:34 2026-08 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB RS 2020-11-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB RS 2020-11-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213302-001 ATENOLOL AND CHLORTHALIDONE 50MG;25MG TABLET / ORAL AB 2020-11-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213302-002 ATENOLOL AND CHLORTHALIDONE 100MG;25MG TABLET / ORAL AB 2020-11-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 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 and Chlorthalidone
Listing expiration 2027-12-31 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 50VV3VW0TI Internal UNII lookup Q0MQD1073Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197382 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 70518-4111-0 Atenolol and Chlorthalidone 90 in 1 BOTTLE, PLASTIC TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70518-4111 ATENOLOL AND CHLORTHALIDONE TABLET [REMEDYREPACK INC.] 1 Current NDC, 1 package rows 20240627_dfbd0160-f56a-41b9-a4ff-eb2df73b1e9b.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 Sample Exclude flag Status 70518-4111-0 70518411100 90 TABLET in 1 BOTTLE, PLASTIC (70518-4111-0) 90 tablet 2024-06-25 No No Current