Candesartan cilexetil

Product NDC: 49884-659
Requested package NDC: 49884-659-09
11-digit product format: 498840659
Labeler code: 49884
Product ID: 49884-659_17510ed6-8915-41ab-9f20-8572368f2235
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Candesartan cilexetil
Dosage form: TABLET
Route: ORAL
Labeler: Par Pharmaceutical Inc.
Application: NDA020838
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2013-05-21
Marketing end: 0000-00-00
Substance: CANDESARTAN CILEXETIL
Active strength: 8 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49884-659	49884-659-09	D	Discontinued by firm		2026-08-03

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	RLD / RS	Approval date
N020838-001	ATACAND	CANDESARTAN CILEXETIL	4MG	TABLET / ORAL	AB	RLD	1998-06-04
N020838-002	ATACAND	CANDESARTAN CILEXETIL	8MG	TABLET / ORAL	AB	RLD	1998-06-04
N020838-003	ATACAND	CANDESARTAN CILEXETIL	16MG	TABLET / ORAL	AB	RLD	1998-06-04
N020838-004	ATACAND	CANDESARTAN CILEXETIL	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020838-001	AB
N020838-002	AB
N020838-003	AB
N020838-004	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020838-001	ATACAND	4MG	TABLET / ORAL	AB	RLD	1998-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020838-002	ATACAND	8MG	TABLET / ORAL	AB	RLD	1998-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020838-003	ATACAND	16MG	TABLET / ORAL	AB	RLD	1998-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020838-004	ATACAND	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020838-001	ATACAND	4MG	TABLET / ORAL	AB	RLD	1998-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020838-002	ATACAND	8MG	TABLET / ORAL	AB	RLD	1998-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020838-003	ATACAND	16MG	TABLET / ORAL	AB	RLD	1998-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020838-004	ATACAND	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020838-001	ATACAND	4MG	TABLET / ORAL	AB	RLD	1998-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020838-002	ATACAND	8MG	TABLET / ORAL	AB	RLD	1998-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020838-003	ATACAND	16MG	TABLET / ORAL	AB	RLD	1998-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020838-004	ATACAND	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020838-001	ATACAND	4MG	TABLET / ORAL	AB	RLD	1998-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020838-002	ATACAND	8MG	TABLET / ORAL	AB	RLD	1998-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020838-003	ATACAND	16MG	TABLET / ORAL	AB	RLD	1998-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020838-004	ATACAND	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020838-001	ATACAND	4MG	TABLET / ORAL	AB	RLD	1998-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020838-002	ATACAND	8MG	TABLET / ORAL	AB	RLD	1998-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020838-003	ATACAND	16MG	TABLET / ORAL	AB	RLD	1998-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020838-004	ATACAND	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020838-001	ATACAND	4MG	TABLET / ORAL	AB	RLD	1998-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020838-002	ATACAND	8MG	TABLET / ORAL	AB	RLD	1998-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020838-003	ATACAND	16MG	TABLET / ORAL	AB	RLD	1998-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020838-004	ATACAND	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020838-001	ATACAND	4MG	TABLET / ORAL	AB	RLD	1998-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020838-002	ATACAND	8MG	TABLET / ORAL	AB	RLD	1998-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020838-003	ATACAND	16MG	TABLET / ORAL	AB	RLD	1998-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020838-004	ATACAND	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020838-001	ATACAND	4MG	TABLET / ORAL	AB	RLD	1998-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020838-002	ATACAND	8MG	TABLET / ORAL	AB	RLD	1998-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020838-003	ATACAND	16MG	TABLET / ORAL	AB	RLD	1998-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020838-004	ATACAND	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020838-001	ATACAND	4MG	TABLET / ORAL	AB	RLD	1998-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020838-002	ATACAND	8MG	TABLET / ORAL	AB	RLD	1998-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020838-003	ATACAND	16MG	TABLET / ORAL	AB	RLD	1998-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020838-004	ATACAND	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020838-001	ATACAND	4MG	TABLET / ORAL	AB	RLD	1998-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020838-002	ATACAND	8MG	TABLET / ORAL	AB	RLD	1998-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020838-003	ATACAND	16MG	TABLET / ORAL	AB	RLD	1998-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020838-004	ATACAND	32MG	TABLET / ORAL	AB	RLD, RS	1998-06-04	`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	N020838-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020838-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020838-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020838-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020838-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020838-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020838-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020838-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020838-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020838-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020838-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020838-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020838-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020838-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020838-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020838-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020838-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020838-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020838-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020838-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020838-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020838-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020838-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020838-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020838-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020838-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020838-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020838-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020838-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020838-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020838-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020838-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020838-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020838-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020838-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020838-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020838-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020838-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020838-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020838-004	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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-659-09	EA - Each	49884-659	4b04ad86-a467-427d-abe2-c592d3c1d40a	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CANDESARTAN CILEXETIL	ACTIVE INGREDIENT	R85M2X0D68	CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]	4
CANDESARTAN	ACTIVE MOIETY	S8Q36MD2XX	CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]	4
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]	4
CANDESARTAN CILEXETIL	ACTIVE INGREDIENT	R85M2X0D68	CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]	1
CANDESARTAN	ACTIVE MOIETY	S8Q36MD2XX	CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]	1
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CANDESARTAN CILEXETIL TABLET [AMERICAN HEALTH PACKAGING]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-659	CANDESARTAN CILEXETIL TABLET [PAR PHARMACEUTICAL INC.]	12	Legacy NDC	20240406_1c90aa68-cc12-41ef-aebc-2616ae45683a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Candesartan cilexetil	CANDESARTAN CILEXETIL	Golden State Medical Supply, Inc.	15601654-76da-04cf-e063-6394a90a2cb5	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020838 application number: NDA020838
ATACAND	CANDESARTAN CILEXETIL	ANI Pharmaceuticals, Inc.	94a59260-d2b6-464a-b5b9-bbc599e57e10	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020838 application number: NDA020838
Candesartan cilexetil	CANDESARTAN CILEXETIL	ANI Pharmaceuticals, Inc.	4621249c-1f44-4d95-8513-a1a2b1859e41	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020838 application number: NDA020838

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-659-09	49884065909	90 TABLET in 1 BOTTLE (49884-659-09)	90 tablet	2013-05-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Candesartan cilexetil	Bryant Ranch Prepack	2025-10-30	HUMAN PRESCRIPTION DRUG LABEL	101
Candesartan cilexetil	Par Pharmaceutical Inc.	2025-07-28	HUMAN PRESCRIPTION DRUG LABEL	13
Candesartan cilexetil	American Health Packaging	2024-10-14	HUMAN PRESCRIPTION DRUG LABEL	10
Candesartan cilexetil	Bryant Ranch Prepack	2024-06-11	HUMAN PRESCRIPTION DRUG LABEL	105