Chlorthalidone

Product NDC: 82804-317
11-digit product format: 828040317
Labeler code: 82804
Product ID: 82804-317_73db0625-00f2-4fc9-9095-c64bccdda33d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA213412
Marketing category: ANDA
Marketing start: 2020-02-13
Substance: CHLORTHALIDONE
Active strength: 25 mg/1
Pharmacologic classes: Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A213412-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11
A213412-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS	2020-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213412-001	AB
A213412-002	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 2 · 78 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	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS	2020-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS	2020-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213412-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2020-02-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213412-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2020-02-11	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A213412-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213412-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213412-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213412-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213412-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213412-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213412-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213412-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213412-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213412-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213412-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213412-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213412-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213412-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213412-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213412-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213412-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213412-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213412-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213412-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213412-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213412-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213412-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213412-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213412-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213412-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213412-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213412-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213412-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213412-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213412-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213412-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213412-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213412-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213412-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213412-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213412-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213412-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213412-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213412-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Chlorthalidone
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORTHALIDONE	25 mg/1

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	REMEDYREPACK INC.	7d8e26e6-7314-4799-b137-934926d343b0	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	583992c2-b789-4267-9a8f-c1ee5db3f29f	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	7d09c992-22f7-41e1-a836-380712f242c0	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	d61367af-530b-4e5e-8e71-11c93f75ecf1	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Direct_Rx	401ae38b-2eb8-c9fc-e063-6294a90af220	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	165e5993-eb9d-4664-97dc-574ae5e0e946	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Ascend Laboratories, LLC	d104583e-e983-4230-b6d1-4455ee1060a5	2025-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Coupler LLC	2ccba8ab-4c34-af52-e063-6394a90a78d3	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	e727d42f-e4e1-4cf6-9d7a-6ec2333bc6d1	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	a1ab541b-7515-4888-b3e0-aca52875562d	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	98f4a14c-2863-4068-bd35-aaedcc872680	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412
Chlorthalidone	CHLORTHALIDONE	A-S Medication Solutions	c5796482-ad1f-437a-ae80-c288880f4100	2023-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213412 application number: ANDA213412

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	Sample	Exclude flag	Status
82804-317-30	82804031730	30 TABLET in 1 BOTTLE (82804-317-30)	30 tablet	2026-09-23	No	No	Current