Diovan HCT

Product NDC: 0078-0314
11-digit product format: 000780314
Labeler code: 0078
Product ID: 0078-0314_c42c209a-1ad4-43a9-a4f6-33a435fb44e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valsartan and hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA020818
Marketing category: NDA
Marketing start: 1998-03-06
Substance: HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength: 12.5; 80 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: 2027-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020818-001	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06
N020818-002	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06
N020818-003	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17
N020818-004	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28
N020818-005	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N020818-001	AB
N020818-002	AB
N020818-003	AB
N020818-004	AB
N020818-005	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 6 · 205 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	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-001	DIOVAN HCT	12.5MG;80MG	TABLET / ORAL	AB	RLD	1998-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-002	DIOVAN HCT	12.5MG;160MG	TABLET / ORAL	AB	RLD	1998-03-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-003	DIOVAN HCT	25MG;160MG	TABLET / ORAL	AB	RLD	2002-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-004	DIOVAN HCT	12.5MG;320MG	TABLET / ORAL	AB	RLD	2006-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-005	DIOVAN HCT	25MG;320MG	TABLET / ORAL	AB	RLD, RS	2006-04-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	N020818-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020818-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020818-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020818-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020818-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020818-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020818-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020818-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020818-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020818-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diovan HCT
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VALSARTAN	12.5 mg/1
HYDROCHLOROTHIAZIDE	80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
80M03YXJ7I	Internal UNII lookup
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200284	Internal RxNorm lookup
200285	Internal RxNorm lookup
349353	Internal RxNorm lookup
636042	Internal RxNorm lookup
636045	Internal RxNorm lookup
809014	Internal RxNorm lookup
809018	Internal RxNorm lookup
809022	Internal RxNorm lookup
809026	Internal RxNorm lookup
809030	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d76a0419-05ee-437e-884c-65807aea9569	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
692a3434-fece-49c6-9b7d-ed7aefc52b50	Product name	3	20260317
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
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
e7dfdaab-7cf9-4f89-804c-eff5108d94d1	Product name	9	20250305
b6abae2f-ee27-47bc-b150-54dc8d969483	Product name	2	20250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519	Product name	2	20231208
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
f5231d08-c52b-a5a0-ba93-675895c292be	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0078-0314-34	Diovan HCT	90 in 1 BOTTLE	TABLET, FILM COATED	90		34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0314-06	EA - Each	0078-0314	09e9485a-a8d0-4231-bb29-48297943bb57	1	2012-07-24
0078-0314-34	EA - Each	0078-0314	fc11836a-911d-4fb8-9959-9f75d8453cd5	1	2012-07-24
0078-0314-61	EA - Each	0078-0314	caed8f2f-5e55-4a9e-bfc5-3492f18113c3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	17
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	4
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	DIOVAN HCT (HYDROCHLOROTHIAZIDE, VALSARTAN) TABLET, FILM COATED [STAT RX USA LLC]	1
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN HCT (HYDROCHLOROTHIAZIDE, VALSARTAN) TABLET, FILM COATED [STAT RX USA LLC]	1
VALSARTAN	ACTIVE INGREDIENT	80M03YXJ7I	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	DIOVAN HCT (HYDROCHLOROTHIAZIDE, VALSARTAN) TABLET, FILM COATED [STAT RX USA LLC]	1
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN HCT (HYDROCHLOROTHIAZIDE, VALSARTAN) TABLET, FILM COATED [STAT RX USA LLC]	1
VALSARTAN	ACTIVE MOIETY	80M03YXJ7I	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0314	DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	32	Current NDC, Legacy NDC, 1 package rows	20250110_d76a0419-05ee-437e-884c-65807aea9569.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
Diovan HCT	VALSARTAN AND HYDROCHLOROTHIAZIDE	Novartis Pharmaceuticals Corporation	d76a0419-05ee-437e-884c-65807aea9569	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020818 application number: NDA020818 ndc (product): 0078-0314

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
80M03YXJ7I	VALSARTAN	137862-53-4	VALSARTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
809018	Diovan HCT 160 MG / 12.5 MG Oral Tablet	PSN	d76a0419-05ee-437e-884c-65807aea9569	34
809022	Diovan HCT 160 MG / 25 MG Oral Tablet	PSN	d76a0419-05ee-437e-884c-65807aea9569	34
809026	Diovan HCT 320 MG / 12.5 MG Oral Tablet	PSN	d76a0419-05ee-437e-884c-65807aea9569	34
809030	Diovan HCT 320 MG / 25 MG Oral Tablet	PSN	d76a0419-05ee-437e-884c-65807aea9569	34
809014	Diovan HCT 80 MG / 12.5 MG Oral Tablet	PSN	d76a0419-05ee-437e-884c-65807aea9569	34
200284	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet	PSN	d76a0419-05ee-437e-884c-65807aea9569	34
200285	valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	d76a0419-05ee-437e-884c-65807aea9569	34
349353	valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	d76a0419-05ee-437e-884c-65807aea9569	34
636042	valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	d76a0419-05ee-437e-884c-65807aea9569	34
636045	valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	d76a0419-05ee-437e-884c-65807aea9569	34
809018	hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Diovan HCT]	SBD	d76a0419-05ee-437e-884c-65807aea9569	34
809026	hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [Diovan HCT]	SBD	d76a0419-05ee-437e-884c-65807aea9569	34
809014	hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]	SBD	d76a0419-05ee-437e-884c-65807aea9569	34
809022	hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [Diovan HCT]	SBD	d76a0419-05ee-437e-884c-65807aea9569	34
809030	hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet [Diovan HCT]	SBD	d76a0419-05ee-437e-884c-65807aea9569	34
200285	hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	d76a0419-05ee-437e-884c-65807aea9569	34
636042	hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet	SCD	d76a0419-05ee-437e-884c-65807aea9569	34
200284	hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet	SCD	d76a0419-05ee-437e-884c-65807aea9569	34
349353	hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	d76a0419-05ee-437e-884c-65807aea9569	34
636045	hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet	SCD	d76a0419-05ee-437e-884c-65807aea9569	34
809018	Diovan HCT 160/12.5 (valsartan / HCTZ) Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809018	Diovan HCT 160/12.5 Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809022	Diovan HCT 160/25 (valsartan / HCTZ) Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809022	Diovan HCT 160/25 Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809026	Diovan HCT 320/12.5 (valsartan / HCTZ) Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809026	Diovan HCT 320/12.5 Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809030	Diovan HCT 320/25 (valsartan / HCTZ) Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809030	Diovan HCT 320/25 Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809014	Diovan HCT 80/12.5 (valsartan / HCTZ) Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809014	Diovan HCT 80/12.5 Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
200285	HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809018	HCTZ 12.5 MG / valsartan 160 MG Oral Tablet [Diovan HCT]	SY	d76a0419-05ee-437e-884c-65807aea9569	34
636042	HCTZ 12.5 MG / valsartan 320 MG Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809026	HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [Diovan HCT]	SY	d76a0419-05ee-437e-884c-65807aea9569	34
200284	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809014	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]	SY	d76a0419-05ee-437e-884c-65807aea9569	34
349353	HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809022	HCTZ 25 MG / valsartan 160 MG Oral Tablet [Diovan HCT]	SY	d76a0419-05ee-437e-884c-65807aea9569	34
636045	HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809030	HCTZ 25 MG / valsartan 320 MG Oral Tablet [Diovan HCT]	SY	d76a0419-05ee-437e-884c-65807aea9569	34
809018	Diovan HCT 160 MG / 12.5 MG Oral Tablet	PSN	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809022	Diovan HCT 160 MG / 25 MG Oral Tablet	PSN	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809026	Diovan HCT 320 MG / 12.5 MG Oral Tablet	PSN	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809030	Diovan HCT 320 MG / 25 MG Oral Tablet	PSN	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809014	Diovan HCT 80 MG / 12.5 MG Oral Tablet	PSN	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
200284	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet	PSN	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
200285	valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
349353	valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
636042	valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
636045	valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809018	hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Diovan HCT]	SBD	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809026	hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [Diovan HCT]	SBD	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809014	hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]	SBD	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809022	hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [Diovan HCT]	SBD	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809030	hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet [Diovan HCT]	SBD	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
200285	hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet	SCD	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
636042	hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet	SCD	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
200284	hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet	SCD	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
349353	hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet	SCD	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
636045	hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet	SCD	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809018	Diovan HCT 160/12.5 (valsartan / HCTZ) Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809018	Diovan HCT 160/12.5 Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809022	Diovan HCT 160/25 (valsartan / HCTZ) Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809022	Diovan HCT 160/25 Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809026	Diovan HCT 320/12.5 (valsartan / HCTZ) Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809026	Diovan HCT 320/12.5 Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809030	Diovan HCT 320/25 (valsartan / HCTZ) Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809030	Diovan HCT 320/25 Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809014	Diovan HCT 80/12.5 (valsartan / HCTZ) Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809014	Diovan HCT 80/12.5 Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
200285	HCTZ 12.5 MG / valsartan 160 MG Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809018	HCTZ 12.5 MG / valsartan 160 MG Oral Tablet [Diovan HCT]	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
636042	HCTZ 12.5 MG / valsartan 320 MG Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809026	HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [Diovan HCT]	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
200284	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809014	HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
349353	HCTZ 25 MG / valsartan 160 MG Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809022	HCTZ 25 MG / valsartan 160 MG Oral Tablet [Diovan HCT]	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
636045	HCTZ 25 MG / valsartan 320 MG Oral Tablet	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4
809030	HCTZ 25 MG / valsartan 320 MG Oral Tablet [Diovan HCT]	SY	cb04fbc5-7d84-4e0d-9020-70b73024ed77	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0314-34	00078031434	90 TABLET, FILM COATED in 1 BOTTLE (0078-0314-34)	1998-03-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diovan HCT	Novartis Pharmaceuticals Corporation	2026-02-13	HUMAN PRESCRIPTION DRUG LABEL	34
Diovan HCT	Dispensing Solutions, Inc. \| PSS World Medical Inc.	2012-10-10	HUMAN PRESCRIPTION DRUG LABEL	1
Diovan HCT	Physicians Total Care, Inc.	2012-01-09	HUMAN PRESCRIPTION DRUG LABEL	4
DIOVAN HCT - STAT RX USA LLC	STAT RX USA LLC	2009-12-28	HUMAN PRESCRIPTION DRUG LABEL	1