Home NDC 61570-024 THALITONE
Product NDC 61570-024
11-digit product format 615700024
Labeler code 61570
Product ID 61570-024_eef51cdb-7214-4c23-8cfc-6ad41eca14ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Monarch Pharmaceuticals, Inc
Application NDA019574
Marketing category NDA
Marketing start 1988-12-20
Marketing end 0000-00-00
Substance CHLORTHALIDONE
Active strength 15 mg/1
Pharmacologic classes Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC exclude flag E
Listing certified through 2017-12-31
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 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61570-024-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61570-024-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61570-024-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61570-024-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61570-024-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61570-024-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61570-024-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61570-024-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61570-024-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61570-024-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61570-024-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61570-024-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N019574-001 THALITONE CHLORTHALIDONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 N019574-002 THALITONE CHLORTHALIDONE 25MG TABLET / ORAL RLD 1992-02-12
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 · 84 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 2026-08-18 06:07:40 2026-07 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019574-002 THALITONE 25MG TABLET / ORAL RLD 1992-02-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019574-001 THALITONE 15MG TABLET / ORAL RLD 1988-12-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019574-001 THALITONE 15MG TABLET / ORAL RLD 1988-12-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET / ORAL RLD 1988-12-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019574-002 THALITONE 25MG TABLET / ORAL 1992-02-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 bb7c543d1eb4…
Observed Orange Book normalized TE history# 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.