Candesartan Cilexetil and Hydrochlorothiazide

Product NDC: 0378-3002
Requested package NDC: 0378-3002-77
11-digit product format: 003783002
Labeler code: 0378
Product ID: 0378-3002_0cc4e1bb-e78c-4a7a-9aee-999399ea5a45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: candesartan cilexetil and hydrochlorothiazide
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA090704
Marketing category: ANDA
Marketing start: 2012-12-04
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: 2022-12-31
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	0378-3002	0378-3002-77	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04
A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04
A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090704-001	AB
A090704-002	AB
A090704-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090704-002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090704-003	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET / ORAL	AB	2012-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090704-001	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET / ORAL	AB	2012-12-04	`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	A090704-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090704-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090704-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090704-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090704-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090704-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090704-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090704-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090704-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090704-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090704-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090704-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090704-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090704-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090704-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090704-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090704-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090704-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090704-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090704-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090704-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090704-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090704-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090704-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090704-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090704-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090704-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090704-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090704-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090704-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090704-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090704-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090704-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090704-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090704-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090704-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090704-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090704-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090704-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090704-001	AB	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
03f056e9-4354-02cc-6010-79c6c9eaac0a	Product name	6	20250521
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-3002-77	Candesartan Cilexetil and Hydrochlorothiazide	90 in 1 BOTTLE, PLASTIC	TABLET	90		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3002-05	EA - Each	0378-3002	32c3837d-810d-4826-8ebc-3e4671d52077	1	2013-02-13
0378-3002-77	EA - Each	0378-3002	a8556359-24bb-495f-98f5-fe4b0d9ae4f1	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CANDESARTAN CILEXETIL	ACTIVE INGREDIENT	R85M2X0D68	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
CANDESARTAN	ACTIVE MOIETY	S8Q36MD2XX	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-3002	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE TABLET [MYLAN PHARMACEUTICALS INC.]	14	Legacy NDC, 1 package rows	20250117_f3c4f7ed-e667-4528-a675-b032c2a4425d.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 and Hydrochlorothiazide	CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	Mylan Pharmaceuticals Inc.	f3c4f7ed-e667-4528-a675-b032c2a4425d	2020-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090704 application number: ANDA090704 ndc (package): 0378-3002-77 ndc (product): 0378-3002 ndc11 (package): 00378300277

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
578325	candesartan cilexetil 16 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	f3c4f7ed-e667-4528-a675-b032c2a4425d	15
578330	candesartan cilexetil 32 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	f3c4f7ed-e667-4528-a675-b032c2a4425d	15
802749	candesartan cilexetil 32 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	f3c4f7ed-e667-4528-a675-b032c2a4425d	15
578325	candesartan cilexetil 16 MG / hydrochlorothiazide 12.5 MG Oral Tablet	SCD	f3c4f7ed-e667-4528-a675-b032c2a4425d	15
578330	candesartan cilexetil 32 MG / hydrochlorothiazide 12.5 MG Oral Tablet	SCD	f3c4f7ed-e667-4528-a675-b032c2a4425d	15
802749	candesartan cilexetil 32 MG / hydrochlorothiazide 25 MG Oral Tablet	SCD	f3c4f7ed-e667-4528-a675-b032c2a4425d	15
578325	candesartan cilexetil 16 MG / HCTZ 12.5 MG Oral Tablet	SY	f3c4f7ed-e667-4528-a675-b032c2a4425d	15
578330	candesartan cilexetil 32 MG / HCTZ 12.5 MG Oral Tablet	SY	f3c4f7ed-e667-4528-a675-b032c2a4425d	15
802749	candesartan cilexetil 32 MG / HCTZ 25 MG Oral Tablet	SY	f3c4f7ed-e667-4528-a675-b032c2a4425d	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-3002-77	00378300277	90 TABLET in 1 BOTTLE, PLASTIC (0378-3002-77)	90 tablet	2012-12-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Candesartan Cilexetil and Hydrochlorothiazide - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2020-08-15	HUMAN PRESCRIPTION DRUG LABEL	15