Chlorthalidone

Product NDC: 55289-067
11-digit product format: 552890067
Labeler code: 55289
Product ID: 55289-067_4198ea35-1b74-f175-e063-6294a90a412e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA086831
Marketing category: ANDA
Marketing start: 1981-02-26
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

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086831-001	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086831-002	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A086831-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086831-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086831-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086831-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086831-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086831-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086831-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086831-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086831-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086831-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086831-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086831-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086831-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086831-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086831-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086831-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086831-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086831-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086831-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086831-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086831-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086831-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086831-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086831-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086831-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086831-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086831-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A086831-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086831-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086831-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086831-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086831-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086831-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086831-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086831-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086831-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086831-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086831-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086831-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086831-002	AB	1	`782e0a99824c…`

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
bb7112ae-3a37-4525-8c7f-c0f4100ffc0a	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
55289-067-30	Chlorthalidone	30 in 1 BOTTLE, PLASTIC	TABLET	30		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-067-30	EA - Each	55289-067	9a8a0795-5f39-4768-82f4-b8daeb71bb8c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORTHALIDONE	ACTIVE INGREDIENT	Q0MQD1073Q	CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
CHLORTHALIDONE	ACTIVE MOIETY	Q0MQD1073Q	CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55289-067	CHLORTHALIDONE TABLET [PD-RX PHARMACEUTICALS, INC.]	17	Current NDC, Legacy NDC, 1 package rows	20241011_bb7112ae-3a37-4525-8c7f-c0f4100ffc0a.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 · 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 ndc (product): 55289-067
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

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	bb7112ae-3a37-4525-8c7f-c0f4100ffc0a	18
197499	chlorthalidone 25 MG Oral Tablet	SCD	bb7112ae-3a37-4525-8c7f-c0f4100ffc0a	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55289-067-30	55289006730	30 TABLET in 1 BOTTLE, PLASTIC (55289-067-30)	30 tablet	2016-03-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlorthalidone - PD-Rx Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	19