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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61570-024		D	Discontinued by firm		2026-07-31
excluded package	package	61570-024	61570-024-01	D	Discontinued by firm		2026-07-31

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N019574-001	THALITONE	CHLORTHALIDONE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1988-12-20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.

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
2026-08-01 22:54:32	2026-06	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	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N019574-002	THALITONE	25MG	TABLET / ORAL		RLD	1992-02-12	`a50c72e98297…`

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.

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61570-024-01	EA - Each	61570-024	27a0b796-8702-4cbe-9862-fcd8cd8d3e83	1	2012-07-24