Home NDC 70199-001-01 Thalitone
Product NDC 70199-001
Requested package NDC 70199-001-01
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 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date N019574-001 THALITONE CHLORTHALIDONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 N019574-002 THALITONE CHLORTHALIDONE 25MG TABLET / ORAL RLD 1992-02-12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 · 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UTC 2026-02 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD,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of this ZIP 2025-12 N019574-001 THALITONE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1988-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019574-002 THALITONE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…2021-12-28 21:50 UTC 2021-12 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 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019574-002 THALITONE 25MG TABLET / ORAL BX RLD, RS 1992-02-12 782e0a99824c…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels 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 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
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