ATACAND HCT

Product NDC: 63629-3377
11-digit product format: 636293377
Labeler code: 63629
Product ID: 63629-3377_10548eb6-bfd4-4083-9bcf-6831ad0dd210
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Candesartan cilexetil and Hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA021093
Marketing category: NDA
Marketing start: 2000-09-28
Marketing end: 0000-00-00
Substance: CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Active strength: 32 mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-3377		D	Discontinued by firm	2026-08-03
excluded package	package	63629-3377	63629-3377-1	D	Discontinued by firm	2026-08-03
excluded package	package	63629-3377	63629-3377-2	D	Discontinued by firm	2026-08-03
excluded package	package	63629-3377	63629-3377-3	D	Discontinued by firm	2026-08-03
excluded package	package	63629-3377	63629-3377-4	D	Discontinued by firm	2026-08-03

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3377-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3377-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3377-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-3377-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3377-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3377-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3377-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-3377-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3377-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3377-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3377-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-3377-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3377-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3377-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3377-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-3377-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3377-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3377-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3377-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-3377-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3377-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3377-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3377-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-3377-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3377-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3377-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3377-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-3377-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3377-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3377-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3377-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-3377-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3377-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3377-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3377-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-3377-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3377-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3377-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3377-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-3377-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3377-2	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3377-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3377-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-3377-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3377-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3377-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3377-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-3377-1	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021093-001	ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05
N021093-002	ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05
N021093-003	ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021093-001	AB
N021093-002	AB
N021093-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-002	ATACAND HCT	32MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-003	ATACAND HCT	32MG;25MG	TABLET / ORAL	AB	RLD, RS	2008-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021093-001	ATACAND HCT	16MG;12.5MG	TABLET / ORAL	AB	RLD	2000-09-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N021093-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021093-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021093-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021093-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021093-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021093-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021093-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021093-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021093-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021093-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021093-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021093-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021093-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021093-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021093-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021093-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021093-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021093-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021093-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021093-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3377-1	EA - Each	63629-3377	a806cbf1-c2bc-407d-868b-b069b0dc6ebe	1	2013-02-13
63629-3377-2	EA - Each	63629-3377	a80b9aa9-24bf-4c8d-a928-f6b78ba0910f	1	2013-02-13
63629-3377-3	EA - Each	63629-3377	53eb546d-c366-45cb-af70-929ef2f3bbb7	1	2013-02-13
63629-3377-4	EA - Each	63629-3377	0581a763-a305-4aa8-8679-8ecb7127ae5a	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CANDESARTAN CILEXETIL	ACTIVE INGREDIENT	R85M2X0D68	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000
CANDESARTAN	ACTIVE MOIETY	S8Q36MD2XX	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ATACAND HCT (CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE) TABLET [BRYANT RANCH PREPACK]	1000

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATACAND HCT	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	ANI Pharmaceuticals, Inc.	d91152c4-66ba-466f-b4f9-0da628d42b1d	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021093 application number: NDA021093
Candesartan Cilexetil and Hydrochlorothiazide	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	ANI Pharmaceuticals, Inc.	bd8d318d-167a-4b26-935d-265dde3193de	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021093 application number: NDA021093

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R85M2X0D68	CANDESARTAN CILEXETIL	145040-37-5	CANDESARTAN CILEXETIL
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-3377-1	63629337701	30 TABLET in 1 BOTTLE (63629-3377-1)	30 tablet	2007-02-23	0000-00-00	No	No	Current
63629-3377-2	63629337702	60 TABLET in 1 BOTTLE (63629-3377-2)	60 tablet	2007-02-23	0000-00-00	No	No	Current
63629-3377-3	63629337703	90 TABLET in 1 BOTTLE (63629-3377-3)	90 tablet	2007-02-23	0000-00-00	No	No	Current
63629-3377-4	63629337704	180 TABLET in 1 BOTTLE (63629-3377-4)	180 tablet	2007-02-23	0000-00-00	No	No	Current