Home NDC 70199-001 Thalitone
Product NDC 70199-001
11-digit product format 701990001
Labeler code 70199
Product ID 70199-001_fbaeb9d5-4b22-4528-9421-9954e53887c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name chlorthalidone
Dosage form TABLET
Route ORAL
Labeler Casper Pharma LLC
Application NDA019574
Marketing category NDA
Marketing start 2019-11-27
Substance CHLORTHALIDONE
Active strength 25 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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date N019574-001 THALITONE CHLORTHALIDONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 N019574-002 THALITONE CHLORTHALIDONE 25MG TABLET / ORAL RLD 1992-02-12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N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019574-002 THALITONE 25MG TABLET / ORAL RLD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UTC 2026-02 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD,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# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70199-001-01 Thalitone 100 in 1 BOTTLE TABLET 100 6 70199-001-30 Thalitone 30 in 1 BOTTLE TABLET 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70199-001 THALITONE (CHLORTHALIDONE) TABLET THALITONE (CHLORTHALIDONE) TABLET [CASPER PHARMA LLC] 6 Current NDC, Legacy NDC, 2 package rows 20210617_bc5a0299-115b-4e60-bb3f-c75a95c51c15.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 · 1 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 70199-001-01 70199000101 100 TABLET in 1 BOTTLE (70199-001-01) 100 tablet 2019-11-27 0000-00-00 No No Current 70199-001-30 70199000130 30 TABLET in 1 BOTTLE (70199-001-30) 30 tablet 2019-11-27 0000-00-00 No No Current