FDA.reportPublic FDA data

Valsartan and Hydrochlorothiazide

Product NDC
68180-105
Requested package NDC
68180-105-09
11-digit product format
681800105
Labeler code
68180
Product ID
68180-105_537df828-cd82-4b5e-9d0d-da8bd1cfd736
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078946
Marketing category
ANDA
Marketing start
2013-03-21
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
25; 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
2026-12-31
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 packagepackage68180-10568180-105-09DDiscontinued by firm2026-10-05

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 43.

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
A078946-001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORAL2013-03-21
A078946-002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORAL2013-03-21
A078946-003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORAL2013-03-21
A078946-004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORAL2013-03-21
A078946-005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORAL2013-03-21

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078946-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORAL2013-03-2184e616aacf4f…
2026-09-14 22:38:342026-08A078946-002VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORAL2013-03-2184e616aacf4f…
2026-09-14 22:38:342026-08A078946-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2013-03-2184e616aacf4f…
2026-09-14 22:38:342026-08A078946-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORAL2013-03-2184e616aacf4f…
2026-09-14 22:38:342026-08A078946-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORAL2013-03-2184e616aacf4f…
2026-08-18 06:07:402026-07A078946-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORAL2013-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078946-002VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORAL2013-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078946-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORAL2013-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078946-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORAL2013-03-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078946-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORAL2013-03-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078946-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078946-002VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078946-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078946-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078946-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078946-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078946-002VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078946-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078946-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078946-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078946-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078946-002VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078946-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078946-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078946-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078946-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078946-002VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078946-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078946-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078946-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078946-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078946-002VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078946-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078946-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078946-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078946-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078946-002VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078946-003VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078946-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2013-03-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078946-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2013-03-2103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 200 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078946-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078946-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078946-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078946-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078946-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078946-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078946-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078946-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078946-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078946-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078946-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078946-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078946-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078946-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078946-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078946-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078946-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078946-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078946-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078946-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078946-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078946-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078946-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078946-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078946-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078946-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078946-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078946-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078946-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078946-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078946-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078946-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078946-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078946-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078946-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078946-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078946-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078946-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078946-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078946-005AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Valsartan and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 mg/1
VALSARTAN160 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 · 5 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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d74a85de-5917-401a-b92d-6a95da5d30a6Available 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
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
68180-105-02Valsartan and Hydrochlorothiazide500 in 1 BOTTLETABLET, FILM COATED50012
68180-105-03Valsartan and Hydrochlorothiazide1000 in 1 BOTTLETABLET, FILM COATED100012
68180-105-09Valsartan and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED9012
68180-105-11Valsartan and Hydrochlorothiazide10 in 1 BLISTER PACKTABLET, FILM COATED1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-105-02EA - Each68180-1058e2530af-2f39-4a0f-9797-1328faaca6ce12013-04-01
68180-105-09EA - Each68180-10575c77857-a2f4-462a-bbd5-45e7e4acb82512013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-105VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 4 package rows20231108_d74a85de-5917-401a-b92d-6a95da5d30a6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.d74a85de-5917-401a-b92d-6a95da5d30a62023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078946
application number: ANDA078946
ndc (package): 68180-105-09
ndc (product): 68180-105
ndc11 (package): 68180010509
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEProficient Rx LPbe008c6a-6036-4abf-a3fc-450465c88d552019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078946
application number: ANDA078946

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletPSNd74a85de-5917-401a-b92d-6a95da5d30a612
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd74a85de-5917-401a-b92d-6a95da5d30a612
349353valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNd74a85de-5917-401a-b92d-6a95da5d30a612
636042valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd74a85de-5917-401a-b92d-6a95da5d30a612
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNd74a85de-5917-401a-b92d-6a95da5d30a612
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCDd74a85de-5917-401a-b92d-6a95da5d30a612
636042hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral TabletSCDd74a85de-5917-401a-b92d-6a95da5d30a612
200284hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral TabletSCDd74a85de-5917-401a-b92d-6a95da5d30a612
349353hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCDd74a85de-5917-401a-b92d-6a95da5d30a612
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCDd74a85de-5917-401a-b92d-6a95da5d30a612
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSYd74a85de-5917-401a-b92d-6a95da5d30a612
636042HCTZ 12.5 MG / valsartan 320 MG Oral TabletSYd74a85de-5917-401a-b92d-6a95da5d30a612
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletSYd74a85de-5917-401a-b92d-6a95da5d30a612
349353HCTZ 25 MG / valsartan 160 MG Oral TabletSYd74a85de-5917-401a-b92d-6a95da5d30a612
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSYd74a85de-5917-401a-b92d-6a95da5d30a612
349353valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN4001ce56-b805-4c38-aa42-945e6f1f3eee3
349353hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCD4001ce56-b805-4c38-aa42-945e6f1f3eee3
349353HCTZ 25 MG / valsartan 160 MG Oral TabletSY4001ce56-b805-4c38-aa42-945e6f1f3eee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-105-096818001050990 TABLET, FILM COATED in 1 BOTTLE (68180-105-09) 2013-03-210000-00-00NoNoCurrent