CHLORTHALIDONE

Product NDC: 68788-4169
Requested package NDC: 68788-4169-9
11-digit product format: 687884169
Labeler code: 68788
Product ID: 68788-4169_da0fe4da-a4f3-4aa8-84f4-4d31c5cbdb0e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA211320
Marketing category: ANDA
Marketing start: 2026-07-24
Substance: CHLORTHALIDONE
Active strength: 25 mg/1
Pharmacologic classes: Increased Diuresis [PE]; Thiazide-like Diuretic [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A211320-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2022-02-09
A211320-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2022-02-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211320-001	AB
A211320-002	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 · 64 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	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211320-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2022-02-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211320-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2022-02-09	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A211320-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211320-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211320-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211320-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211320-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211320-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211320-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211320-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211320-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211320-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211320-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211320-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211320-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211320-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211320-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211320-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211320-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211320-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211320-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211320-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211320-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211320-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211320-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211320-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211320-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211320-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211320-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211320-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211320-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211320-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211320-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211320-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211320-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211320-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211320-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211320-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211320-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211320-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211320-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211320-002	AB	1	`1c564ffb4f44…`

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

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
da0fe4da-a4f3-4aa8-84f4-4d31c5cbdb0e	Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHLORTHALIDONE	CHLORTHALIDONE	Preferred Pharmaceuticals Inc.	da0fe4da-a4f3-4aa8-84f4-4d31c5cbdb0e	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320 ndc (package): 68788-4169-9 ndc (product): 68788-4169 ndc11 (package): 68788416909
CHLORTHALIDONE	CHLORTHALIDONE	Bryant Ranch Prepack	f46fd743-3661-41b7-b12d-30d96692f0ee	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320
CHLORTHALIDONE	CHLORTHALIDONE	REMEDYREPACK INC.	50936b5f-3eb8-4ff8-96b3-0aa4a8f77a98	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320
CHLORTHALIDONE	CHLORTHALIDONE	Rising Pharma Holdings, Inc.	71b1d074-0521-4cd1-beb5-fedd61f52eca	2024-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320
CHLORTHALIDONE	CHLORTHALIDONE	Bryant Ranch Prepack	1ba595d4-b105-4d52-90dd-0fb8bda1fe1b	2023-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320
CHLORTHALIDONE	CHLORTHALIDONE	JUBILANT CADISTA PHARMACEUTICALS,INC.	ca0df4ae-c424-44d2-8611-1637f1a101a8	2022-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211320 application number: ANDA211320

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	Status
68788-4169-9	68788416909	90 TABLET in 1 BOTTLE (68788-4169-9)	90 tablet	2026-07-24	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorthalidone Tablets, USP	Preferred Pharmaceuticals Inc.	2026-07-24	HUMAN PRESCRIPTION DRUG LABEL	1