Candesartan cilexetil

Product NDC: 68151-3838
11-digit product format: 681513838
Labeler code: 68151
Product ID: 68151-3838_076f9f04-922c-4c67-b65c-d8e866761de9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Candesartan cilexetil
Dosage form: TABLET
Route: ORAL
Labeler: Carilion Materials Management
Application: ANDA078702
Marketing category: ANDA
Marketing start: 2013-05-21
Marketing end: 0000-00-00
Substance: CANDESARTAN CILEXETIL
Active strength: 16 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68151-3838		I	Inactivated by FDA		2026-08-03
excluded package	package	68151-3838	68151-3838-9	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68151-3838-9	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68151-3838-9	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68151-3838-9	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68151-3838-9	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68151-3838-9	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68151-3838-9	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68151-3838-9	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68151-3838-9	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68151-3838-9	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68151-3838-9	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68151-3838-9	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68151-3838-9	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68151-3838-9	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68151-3838-9	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68151-3838-9	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68151-3838-9	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68151-3838-9	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68151-3838-9	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68151-3838-9	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68151-3838-9	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68151-3838-9	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68151-3838-9	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078702-001	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03
A078702-002	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03
A078702-003	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03
A078702-004	CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078702-001	AB
A078702-002	AB
A078702-003	AB
A078702-004	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 5 · 164 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	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078702-001	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	2013-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-002	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	2013-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-003	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	2013-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-004	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	2013-05-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A078702-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078702-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078702-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078702-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078702-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078702-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078702-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078702-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078702-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078702-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078702-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078702-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078702-004	AB	1	`d06236e962d9…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
03f056e9-4354-02cc-6010-79c6c9eaac0a	Product name	6	20250521
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-3838-9	2020-01-31	C162847	48780-1	9d75b9d0-7897-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use CANDESARTAN CILEXETIL TABLETS safely and effectively. See full prescribing information for CANDESARTAN CILEXETIL TABLETS. CANDESARTAN CILEXETIL Tablets, for oral use INITIAL U.S. APPROVAL: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68151-3838-9	Candesartan cilexetil	1 in 1 PACKAGE	TABLET	1		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CANDESARTAN CILEXETIL	ACTIVE INGREDIENT	R85M2X0D68	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
CANDESARTAN	ACTIVE MOIETY	S8Q36MD2XX	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-3838	CANDESARTAN CILEXETIL TABLET [CARILION MATERIALS MANAGEMENT]	3	Legacy NDC, 1 package rows	20160806_a67f4f53-76c7-4239-9dd6-fef8e8019e9a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
candesartan cilexetil	CANDESARTAN CILEXETIL	Mylan Pharmaceuticals Inc.	904b357e-97bf-475e-90a5-f0449f2a428e	2021-05-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078702 application number: ANDA078702

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R85M2X0D68	CANDESARTAN CILEXETIL	145040-37-5	CANDESARTAN CILEXETIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577776	candesartan cilexetil 16 MG Oral Tablet	PSN	a67f4f53-76c7-4239-9dd6-fef8e8019e9a	3
577776	candesartan cilexetil 16 MG Oral Tablet	SCD	a67f4f53-76c7-4239-9dd6-fef8e8019e9a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-3838-9	68151383809	1 in 1 PACKAGE	Historical