Application 211627

Type: ANDA
Sponsor: UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHLORTHALIDONE	CHLORTHALIDONE	TABLET;ORAL	25MG	No	No
002	CHLORTHALIDONE	CHLORTHALIDONE	TABLET;ORAL	50MG	No	No

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…`

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 (product): 72189-356
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 ndc (product): 71335-1829
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 ndc (product): 29300-334 ndc (product): 29300-333

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-333	Chlorthalidone	Chlorthalidone	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-333	Chlorthalidone	Chlorthalidone	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-334	Chlorthalidone	Chlorthalidone	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-334	Chlorthalidone	Chlorthalidone	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
71335-1829	Chlorthalidone	Chlorthalidone	Bryant Ranch Prepack	ANDA	Current
72189-356	Chlorthalidone	Chlorthalidone	Direct_Rx	ANDA	Current