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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70199-001	70199-001-01	D	Discontinued by firm		2026-09-14

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
N019574-001	THALITONE	CHLORTHALIDONE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-12-20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 · 86 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	N019574-001	THALITONE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019574-002	THALITONE	25MG	TABLET / ORAL		RLD	1992-02-12	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019574-002	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019574-002	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019574-002	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019574-002	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019574-002	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019574-002	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019574-002	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019574-002	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019574-002	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019574-002	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019574-002	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019574-002	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019574-002	BX	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019574-002	BX	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019574-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019574-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019574-002	BX	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N019574-002	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019574-002	BX	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019574-002	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019574-002	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019574-002	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019574-002	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019574-002	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019574-002	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019574-002	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019574-002	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019574-002	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019574-002	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019574-002	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019574-002	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019574-002	BX	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83fe98fe-2a14-448c-9029-41f7600d1b0a	Product name	1	20260105
0450926f-f624-49c2-83be-42807e8fbcd5	Product name	1	20251113
8525e779-537f-e5cc-2515-089ecce5f50f	Product name	9	20221128
faf41ef3-b4b3-a29e-3b26-07c3009003bf	Product name	5	20220517
3f5e2da3-8b99-f714-3261-2c998ee07b05	Product name	1	20140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5c	Product name	1	20140508

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thalitone	CHLORTHALIDONE	Casper Pharma LLC	bc5a0299-115b-4e60-bb3f-c75a95c51c15	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019574 application number: NDA019574 ndc (package): 70199-001-01 ndc (product): 70199-001 ndc11 (package): 70199000101

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Q0MQD1073Q	CHLORTHALIDONE	77-36-1	CHLORTHALIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197498	chlorthalidone 15 MG Oral Tablet	PSN	bc5a0299-115b-4e60-bb3f-c75a95c51c15	6
197499	chlorthalidone 25 MG Oral Tablet	PSN	bc5a0299-115b-4e60-bb3f-c75a95c51c15	6
214081	THALITONE 15 MG Oral Tablet	PSN	bc5a0299-115b-4e60-bb3f-c75a95c51c15	6
214083	THALITONE 25 MG Oral Tablet	PSN	bc5a0299-115b-4e60-bb3f-c75a95c51c15	6
214081	chlorthalidone 15 MG Oral Tablet [Thalitone]	SBD	bc5a0299-115b-4e60-bb3f-c75a95c51c15	6
214083	chlorthalidone 25 MG Oral Tablet [Thalitone]	SBD	bc5a0299-115b-4e60-bb3f-c75a95c51c15	6
197498	chlorthalidone 15 MG Oral Tablet	SCD	bc5a0299-115b-4e60-bb3f-c75a95c51c15	6
197499	chlorthalidone 25 MG Oral Tablet	SCD	bc5a0299-115b-4e60-bb3f-c75a95c51c15	6
214081	Thalitone 15 MG Oral Tablet	SY	bc5a0299-115b-4e60-bb3f-c75a95c51c15	6
214083	Thalitone 25 MG Oral Tablet	SY	bc5a0299-115b-4e60-bb3f-c75a95c51c15	6

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Thalitone	Casper Pharma LLC \| Aurobindo Pharma Limited	2026-06-25	Human Prescription Drug Label	7