CHLORTHALIDONE

Product NDC: 53808-1105
Requested package NDC: 53808-1105-1
11-digit product format: 538081105
Labeler code: 53808
Product ID: 53808-1105_3fba5f2d-ad65-4fe3-b991-1cf562dbc3dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CHLORTHALIDONE
Dosage form: TABLET
Route: ORAL
Labeler: DOH CENTRAL PHARMACY
Application: ANDA206904
Marketing category: ANDA
Marketing start: 2017-09-19
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: 2020-12-31
Current FDA listing: Historical FDA.report record

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	53808-1105	53808-1105-1	I	Inactivated by FDA		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A206904-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2017-03-30
A206904-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2017-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206904-001	AB
A206904-002	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.

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206904-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2017-03-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206904-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2017-03-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206904-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206904-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206904-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206904-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206904-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206904-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206904-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206904-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206904-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206904-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206904-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206904-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206904-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206904-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206904-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206904-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206904-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206904-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206904-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206904-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206904-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206904-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206904-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206904-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206904-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206904-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206904-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206904-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206904-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206904-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206904-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206904-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206904-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206904-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206904-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206904-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206904-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206904-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206904-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206904-002	AB	1	`74a2ff9319b5…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-1105-1	2024-01-30	C162847	48780-1	1030e365-6753-111a-e063-dadaa90a10e2	CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-1105-1	CHLORTHALIDONE	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-1105	CHLORTHALIDONE TABLET [DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20190116_449a2f00-2860-4956-81ed-704567b1442a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORTHALIDONE	CHLORTHALIDONE	Rising Pharma Holdings, Inc.	f96b2d0b-a141-4efb-8ccc-c447dfc6024a	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206904 application number: ANDA206904
CHLORTHALIDONE	CHLORTHALIDONE	Aphena Pharma Solutions - Tennessee, LLC	aa16c3fe-c00b-4b49-bfe3-3b3f93bd647a	2020-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206904 application number: ANDA206904

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
197499	chlorthalidone 25 MG Oral Tablet	PSN	449a2f00-2860-4956-81ed-704567b1442a	1
197499	chlorthalidone 25 MG Oral Tablet	SCD	449a2f00-2860-4956-81ed-704567b1442a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53808-1105-1	53808110501	30 TABLET in 1 BLISTER PACK (53808-1105-1)	30 tablet	2017-09-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHLORTHALIDONE TABLETS USP, 25 mg and 50 mg	DOH CENTRAL PHARMACY	2019-01-15	HUMAN PRESCRIPTION DRUG LABEL	1