Chlorthalidone

Product NDC: 72189-356
Requested package NDC: 72189-356-60
11-digit product format: 721890356
Labeler code: 72189
Product ID: 72189-356_2c4c9187-3303-d75f-e063-6394a90a9231
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA211627
Marketing category: ANDA
Marketing start: 2022-05-10
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-356	72189-356-60	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-356	72189-356-60	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
A211627-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2019-08-06
A211627-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2019-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211627-001	AB
A211627-002	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 · 80 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
2026-02-19 14:30 UTC	2026-02	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211627-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2019-08-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211627-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2019-08-06	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211627-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211627-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211627-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211627-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211627-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211627-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211627-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211627-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211627-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211627-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211627-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211627-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211627-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211627-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211627-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211627-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211627-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211627-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211627-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211627-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211627-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211627-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211627-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211627-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211627-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211627-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211627-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211627-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211627-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211627-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211627-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211627-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211627-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211627-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211627-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211627-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211627-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211627-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211627-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211627-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Chlorthalidone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORTHALIDONE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Q0MQD1073Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197499	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
deab1d3e-759f-480e-e053-2995a90a0a75	Available on FDA.report

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
72189-356-60	Chlorthalidone	60 in 1 BOTTLE	TABLET	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-356-60	EA - Each	72189-356	4e861fe5-cd98-4613-bb00-c3f7f8474489	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-356	CHLORTHALIDONE TABLET [DIRECT_RX]	2	Current NDC, Legacy NDC, 1 package rows	20250123_deab1d3e-759f-480e-e053-2995a90a0a75.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	a73613a3-914f-481a-8e40-8d782bcea03a	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211627 application number: ANDA211627
Chlorthalidone	CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	db169e46-9f6e-490e-856f-f60ec9a31980	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211627 application number: ANDA211627
Chlorthalidone	CHLORTHALIDONE	Direct_Rx	deab1d3e-759f-480e-e053-2995a90a0a75	2025-01-22	Warnings	Exact identifier application applno (ANDA): 211627 application number: ANDA211627 ndc (package): 72189-356-60 ndc (product): 72189-356 ndc11 (package): 72189035660
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	f19b9a1c-1a43-4317-a016-6104391730dc	2023-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211627 application number: ANDA211627
Chlorthalidone	CHLORTHALIDONE	Unichem Pharmaceuticals (USA), Inc.	01065eda-7515-46bc-b858-a062c3aa35bd	2022-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211627 application number: ANDA211627

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	deab1d3e-759f-480e-e053-2995a90a0a75	2
197499	chlorthalidone 25 MG Oral Tablet	SCD	deab1d3e-759f-480e-e053-2995a90a0a75	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-356-60	72189035660	60 TABLET in 1 BOTTLE (72189-356-60)	60 tablet	2022-05-10	0000-00-00	No	No	Current