Chlorthalidone

Product NDC: 63629-6347
Requested package NDC: 63629-6347-3
11-digit product format: 636296347
Labeler code: 63629
Product ID: 63629-6347_fec18d79-a58d-4c22-bb64-c390659344b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA086831
Marketing category: ANDA
Marketing start: 1981-02-26
Marketing end: 0000-00-00
Substance: CHLORTHALIDONE
Active strength: 25 mg/1
Pharmacologic classes: Thiazide-like Diuretic [EPC],Increased Diuresis [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-6347	63629-6347-3	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
A086831-001	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A086831-002	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A086831-001	AB
A086831-002	AB

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	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982		`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A086831-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A086831-002	AB	1	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	PD-Rx Pharmaceuticals, Inc.	bb7112ae-3a37-4525-8c7f-c0f4100ffc0a	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086831 application number: ANDA086831
Chlorthalidone	CHLORTHALIDONE	Safecor Health, LLC	e0e316f6-96d1-4a89-a3b9-f4f0b4c9c833	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086831 application number: ANDA086831
Chlorthalidone	CHLORTHALIDONE	Mylan Pharmaceuticals Inc.	15dd224a-87ad-48dc-80b1-e8382a452c4c	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086831 application number: ANDA086831
Chlorthalidone	CHLORTHALIDONE	Mylan Institutional Inc.	193c85ba-43c2-4be2-82cf-7b394a83390e	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086831 application number: ANDA086831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-6347-1	2020-10-16	C162847	48780-1	9d75b9cf-fe06-f424-e053-dadaa90a57ce	f167f5ed-f158-4fc0-81c9-0a1277244ef7
63629-6347-2	2020-10-16	C162847	48780-1	9d75b9cf-fe06-f424-e053-dadaa90a57ce	f167f5ed-f158-4fc0-81c9-0a1277244ef7
63629-6347-3	2020-10-16	C162847	48780-1	9d75b9cf-fe06-f424-e053-dadaa90a57ce	f167f5ed-f158-4fc0-81c9-0a1277244ef7
63629-6347-1	2020-01-31	C162847	48780-1	9d75b9cf-fe06-f424-e053-dadaa90a57ce	f167f5ed-f158-4fc0-81c9-0a1277244ef7
63629-6347-2	2020-01-31	C162847	48780-1	9d75b9cf-fe06-f424-e053-dadaa90a57ce	f167f5ed-f158-4fc0-81c9-0a1277244ef7
63629-6347-3	2020-01-31	C162847	48780-1	9d75b9cf-fe06-f424-e053-dadaa90a57ce	f167f5ed-f158-4fc0-81c9-0a1277244ef7

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-6347-3	63629634703	60 TABLET in 1 BOTTLE (63629-6347-3)	60 tablet	2016-02-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorthalidone - Bryant Ranch Prepack	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	4