Chlorthalidone

Product NDC: 71335-0906
11-digit product format: 713350906
Labeler code: 71335
Product ID: 71335-0906_e3cdd491-396b-4c90-b301-9a473c21d7dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlorthalidone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207222
Marketing category: ANDA
Marketing start: 2018-05-28
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 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
A207222-001	CHLORTHALIDONE	CHLORTHALIDONE	25MG	TABLET / ORAL	AB		2018-05-24
A207222-002	CHLORTHALIDONE	CHLORTHALIDONE	50MG	TABLET / ORAL	AB		2018-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207222-001	AB
A207222-002	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	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	BX	2018-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	BX	2018-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	BX	2018-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	BX	2018-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	BX	2018-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	BX	2018-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207222-001	CHLORTHALIDONE	25MG	TABLET / ORAL	AB	2018-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207222-002	CHLORTHALIDONE	50MG	TABLET / ORAL	AB	2018-05-24	`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	A207222-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207222-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207222-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207222-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207222-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207222-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207222-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207222-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207222-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207222-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207222-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207222-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207222-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207222-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207222-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207222-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207222-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207222-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207222-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207222-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207222-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207222-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207222-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207222-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207222-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207222-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207222-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207222-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207222-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207222-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207222-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207222-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207222-001	BX	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207222-002	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207222-001	BX	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207222-002	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207222-001	BX	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207222-002	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207222-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207222-002	AB	1	`74a2ff9319b5…`

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

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
bf09d68f-af7a-4057-92f1-13f1ef85d532	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	SPL version
71335-0906-1	Chlorthalidone	30 in 1 BOTTLE	TABLET	30	8
71335-0906-2	Chlorthalidone	90 in 1 BOTTLE	TABLET	90	8
71335-0906-3	Chlorthalidone	60 in 1 BOTTLE	TABLET	60	8
71335-0906-4	Chlorthalidone	8 in 1 BOTTLE	TABLET	8	8
71335-0906-5	Chlorthalidone	100 in 1 BOTTLE	TABLET	100	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0906	CHLORTHALIDONE TABLET [BRYANT RANCH PREPACK]	8	Current NDC, Legacy NDC, 5 package rows	20250221_bf09d68f-af7a-4057-92f1-13f1ef85d532.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	bf09d68f-af7a-4057-92f1-13f1ef85d532	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222 ndc (product): 71335-0906
Chlorthalidone	CHLORTHALIDONE	Umedica Laboratories USA Inc.	645734ab-d6aa-4368-9a5a-b550e2717770	2026-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	da50019b-60ea-47b3-a355-4ab48efcbe3d	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Northwind Health Company, LLC	da829c8c-ae13-510b-e053-2995a90a70b8	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Northwind Health Company, LLC	df6271ff-f111-fd4a-e053-2a95a90a4b51	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Nivagen Pharmaceuticals, INC.	36ef8d83-45f2-4873-b7cb-1be096d14d18	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	5979af5a-0c5b-40f9-bb67-2d462e1cefb7	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	5441e163-459a-46b0-87a9-e9879091bf3c	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Bryant Ranch Prepack	ac431d1b-b307-46fe-a3a9-29f40fe6742b	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222
Chlorthalidone	CHLORTHALIDONE	Proficient Rx LP	01337f79-4b3d-4749-a82b-8d56c1aec179	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207222 application number: ANDA207222

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	Marketing end	Sample	Exclude flag	Status
71335-0906-1	71335090601	30 TABLET in 1 BOTTLE (71335-0906-1)	30 tablet	2018-07-16	0000-00-00	No	No	Current
71335-0906-2	71335090602	90 TABLET in 1 BOTTLE (71335-0906-2)	90 tablet	2018-07-25	0000-00-00	No	No	Current
71335-0906-3	71335090603	60 TABLET in 1 BOTTLE (71335-0906-3)	60 tablet	2025-01-29	0000-00-00	No	No	Current
71335-0906-4	71335090604	8 TABLET in 1 BOTTLE (71335-0906-4)	8 tablet	2025-01-29	0000-00-00	No	No	Current
71335-0906-5	71335090605	100 TABLET in 1 BOTTLE (71335-0906-5)	100 tablet	2021-05-12	0000-00-00	No	No	Current