Diovan HCT

Product NDC
0078-0315
11-digit product format
000780315
Labeler code
0078
Product ID
0078-0315_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; 160 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

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0078-03150078-0315-15DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020818-001DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORALABRLD1998-03-06
N020818-002DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORALABRLD1998-03-06
N020818-003DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORALABRLD2002-01-17
N020818-004DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORALABRLD2006-04-28
N020818-005DIOVAN HCTHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORALABRLD, RS2006-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020818-001AB
N020818-002AB
N020818-003AB
N020818-004AB
N020818-005AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-001DIOVAN HCT12.5MG;80MGTABLET / ORALABRLD1998-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-002DIOVAN HCT12.5MG;160MGTABLET / ORALABRLD1998-03-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-003DIOVAN HCT25MG;160MGTABLET / ORALABRLD2002-01-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-004DIOVAN HCT12.5MG;320MGTABLET / ORALABRLD2006-04-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-005DIOVAN HCT25MG;320MGTABLET / ORALABRLD, RS2006-04-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020818-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020818-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020818-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020818-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020818-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020818-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020818-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020818-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020818-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020818-005AB15bbf6a4d5a75…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN12.5 mg/1
HYDROCHLOROTHIAZIDE160 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80M03YXJ7IInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d76a0419-05ee-437e-884c-65807aea9569Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
692a3434-fece-49c6-9b7d-ed7aefc52b50Product name320260317
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
e7dfdaab-7cf9-4f89-804c-eff5108d94d1Product name920250305
b6abae2f-ee27-47bc-b150-54dc8d969483Product name220250221
52311e76-a520-4bd2-9d5b-e0b6d6f44519Product name220231208
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508
f5231d08-c52b-a5a0-ba93-675895c292beProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0315-15Diovan HCT30 in 1 BOX, UNIT-DOSETABLET, FILM COATED3034
0078-0315-34Diovan HCT90 in 1 BOTTLETABLET, FILM COATED9034
0078-0315-61Diovan HCT1 in 1 BLISTER PACKTABLET, FILM COATED134

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0315-06EA - Each0078-0315c316dbd4-6da4-4fdb-acfd-fd60a75e8e0612012-07-24
0078-0315-15EA - Each0078-0315f7b71b05-292c-485a-b23d-1fac30b1c25312012-07-24
0078-0315-34EA - Each0078-031594204470-8f15-42cf-874c-39d844e3ff4212012-07-24
0078-0315-61EA - Each0078-0315fbe02239-f8bc-489d-81c9-2b4fb901904912012-07-24
0078-0315-67EA - Each0078-031592252cdc-cdc3-496d-b8e3-bbd4ba2e3fa512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
TALCINACTIVE INGREDIENT7SEV7J4R1UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]17
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
TALCINACTIVE INGREDIENT7SEV7J4R1UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]11
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]4
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
VALSARTANACTIVE INGREDIENT80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
VALSARTANACTIVE MOIETY80M03YXJ7IDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0315DIOVAN HCT (VALSARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]32Current NDC, Legacy NDC, 3 package rows20250110_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diovan HCTVALSARTAN AND HYDROCHLOROTHIAZIDENovartis Pharmaceuticals Corporationd76a0419-05ee-437e-884c-65807aea95692026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020818
application number: NDA020818
ndc (product): 0078-0315

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
809018Diovan HCT 160 MG / 12.5 MG Oral TabletPSNd76a0419-05ee-437e-884c-65807aea956934
809022Diovan HCT 160 MG / 25 MG Oral TabletPSNd76a0419-05ee-437e-884c-65807aea956934
809026Diovan HCT 320 MG / 12.5 MG Oral TabletPSNd76a0419-05ee-437e-884c-65807aea956934
809030Diovan HCT 320 MG / 25 MG Oral TabletPSNd76a0419-05ee-437e-884c-65807aea956934
809014Diovan HCT 80 MG / 12.5 MG Oral TabletPSNd76a0419-05ee-437e-884c-65807aea956934
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletPSNd76a0419-05ee-437e-884c-65807aea956934
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd76a0419-05ee-437e-884c-65807aea956934
349353valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNd76a0419-05ee-437e-884c-65807aea956934
636042valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd76a0419-05ee-437e-884c-65807aea956934
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNd76a0419-05ee-437e-884c-65807aea956934
809018hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Diovan HCT]SBDd76a0419-05ee-437e-884c-65807aea956934
809026hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [Diovan HCT]SBDd76a0419-05ee-437e-884c-65807aea956934
809014hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SBDd76a0419-05ee-437e-884c-65807aea956934
809022hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [Diovan HCT]SBDd76a0419-05ee-437e-884c-65807aea956934
809030hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet [Diovan HCT]SBDd76a0419-05ee-437e-884c-65807aea956934
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDd76a0419-05ee-437e-884c-65807aea956934
636042hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral TabletSCDd76a0419-05ee-437e-884c-65807aea956934
200284hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral TabletSCDd76a0419-05ee-437e-884c-65807aea956934
349353hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCDd76a0419-05ee-437e-884c-65807aea956934
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCDd76a0419-05ee-437e-884c-65807aea956934
809018Diovan HCT 160/12.5 (valsartan / HCTZ) Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809018Diovan HCT 160/12.5 Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809022Diovan HCT 160/25 (valsartan / HCTZ) Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809022Diovan HCT 160/25 Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809026Diovan HCT 320/12.5 (valsartan / HCTZ) Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809026Diovan HCT 320/12.5 Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809030Diovan HCT 320/25 (valsartan / HCTZ) Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809030Diovan HCT 320/25 Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809014Diovan HCT 80/12.5 (valsartan / HCTZ) Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809014Diovan HCT 80/12.5 Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809018HCTZ 12.5 MG / valsartan 160 MG Oral Tablet [Diovan HCT]SYd76a0419-05ee-437e-884c-65807aea956934
636042HCTZ 12.5 MG / valsartan 320 MG Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809026HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [Diovan HCT]SYd76a0419-05ee-437e-884c-65807aea956934
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809014HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SYd76a0419-05ee-437e-884c-65807aea956934
349353HCTZ 25 MG / valsartan 160 MG Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809022HCTZ 25 MG / valsartan 160 MG Oral Tablet [Diovan HCT]SYd76a0419-05ee-437e-884c-65807aea956934
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSYd76a0419-05ee-437e-884c-65807aea956934
809030HCTZ 25 MG / valsartan 320 MG Oral Tablet [Diovan HCT]SYd76a0419-05ee-437e-884c-65807aea956934
809018Diovan HCT 160 MG / 12.5 MG Oral TabletPSNcb04fbc5-7d84-4e0d-9020-70b73024ed774
809022Diovan HCT 160 MG / 25 MG Oral TabletPSNcb04fbc5-7d84-4e0d-9020-70b73024ed774
809026Diovan HCT 320 MG / 12.5 MG Oral TabletPSNcb04fbc5-7d84-4e0d-9020-70b73024ed774
809030Diovan HCT 320 MG / 25 MG Oral TabletPSNcb04fbc5-7d84-4e0d-9020-70b73024ed774
809014Diovan HCT 80 MG / 12.5 MG Oral TabletPSNcb04fbc5-7d84-4e0d-9020-70b73024ed774
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletPSNcb04fbc5-7d84-4e0d-9020-70b73024ed774
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNcb04fbc5-7d84-4e0d-9020-70b73024ed774
349353valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNcb04fbc5-7d84-4e0d-9020-70b73024ed774
636042valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNcb04fbc5-7d84-4e0d-9020-70b73024ed774
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNcb04fbc5-7d84-4e0d-9020-70b73024ed774
809018hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral Tablet [Diovan HCT]SBDcb04fbc5-7d84-4e0d-9020-70b73024ed774
809026hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral Tablet [Diovan HCT]SBDcb04fbc5-7d84-4e0d-9020-70b73024ed774
809014hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SBDcb04fbc5-7d84-4e0d-9020-70b73024ed774
809022hydrochlorothiazide 25 MG / valsartan 160 MG Oral Tablet [Diovan HCT]SBDcb04fbc5-7d84-4e0d-9020-70b73024ed774
809030hydrochlorothiazide 25 MG / valsartan 320 MG Oral Tablet [Diovan HCT]SBDcb04fbc5-7d84-4e0d-9020-70b73024ed774
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDcb04fbc5-7d84-4e0d-9020-70b73024ed774
636042hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral TabletSCDcb04fbc5-7d84-4e0d-9020-70b73024ed774
200284hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral TabletSCDcb04fbc5-7d84-4e0d-9020-70b73024ed774
349353hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCDcb04fbc5-7d84-4e0d-9020-70b73024ed774
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCDcb04fbc5-7d84-4e0d-9020-70b73024ed774
809018Diovan HCT 160/12.5 (valsartan / HCTZ) Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809018Diovan HCT 160/12.5 Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809022Diovan HCT 160/25 (valsartan / HCTZ) Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809022Diovan HCT 160/25 Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809026Diovan HCT 320/12.5 (valsartan / HCTZ) Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809026Diovan HCT 320/12.5 Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809030Diovan HCT 320/25 (valsartan / HCTZ) Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809030Diovan HCT 320/25 Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809014Diovan HCT 80/12.5 (valsartan / HCTZ) Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809014Diovan HCT 80/12.5 Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809018HCTZ 12.5 MG / valsartan 160 MG Oral Tablet [Diovan HCT]SYcb04fbc5-7d84-4e0d-9020-70b73024ed774
636042HCTZ 12.5 MG / valsartan 320 MG Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809026HCTZ 12.5 MG / valsartan 320 MG Oral Tablet [Diovan HCT]SYcb04fbc5-7d84-4e0d-9020-70b73024ed774
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809014HCTZ 12.5 MG / valsartan 80 MG Oral Tablet [Diovan HCT]SYcb04fbc5-7d84-4e0d-9020-70b73024ed774
349353HCTZ 25 MG / valsartan 160 MG Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809022HCTZ 25 MG / valsartan 160 MG Oral Tablet [Diovan HCT]SYcb04fbc5-7d84-4e0d-9020-70b73024ed774
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSYcb04fbc5-7d84-4e0d-9020-70b73024ed774
809030HCTZ 25 MG / valsartan 320 MG Oral Tablet [Diovan HCT]SYcb04fbc5-7d84-4e0d-9020-70b73024ed774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0315-150007803151530 in 1 BOX, UNIT-DOSEHistorical
0078-0315-340007803153490 TABLET, FILM COATED in 1 BOTTLE (0078-0315-34) 1998-03-060000-00-00NoNoCurrent
0078-0315-61000780315611 in 1 BLISTER PACKHistorical