FDA.reportPublic FDA data

Valsartan and Hydrochlorothiazide

Product NDC
51655-243
Requested package NDC
51655-243-52
11-digit product format
516550243
Labeler code
51655
Product ID
51655-243_48e68ff2-bf66-0d69-e063-6294a90a0246
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078020
Marketing category
ANDA
Marketing start
2022-11-16
Substance
VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
320; 25 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 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
A078020-001VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;80MGTABLET / ORALAB2012-09-21
A078020-002VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;160MGTABLET / ORALAB2012-09-21
A078020-003VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;160MGTABLET / ORALAB2012-09-21
A078020-004VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN12.5MG;320MGTABLET / ORALAB2012-09-21
A078020-005VALSARTAN AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; VALSARTAN25MG;320MGTABLET / ORALAB2012-09-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078020-001AB
A078020-002AB
A078020-003AB
A078020-004AB
A078020-005AB

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078020-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2012-09-2184e616aacf4f…
2026-09-14 22:38:342026-08A078020-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2012-09-2184e616aacf4f…
2026-09-14 22:38:342026-08A078020-003VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2012-09-2184e616aacf4f…
2026-09-14 22:38:342026-08A078020-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2012-09-2184e616aacf4f…
2026-09-14 22:38:342026-08A078020-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2012-09-2184e616aacf4f…
2026-08-18 06:07:402026-07A078020-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2012-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078020-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2012-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078020-003VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2012-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078020-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2012-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07A078020-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2012-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078020-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2012-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078020-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2012-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078020-003VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2012-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078020-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2012-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078020-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2012-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078020-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2012-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078020-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2012-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078020-003VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2012-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078020-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2012-09-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078020-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2012-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078020-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2012-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078020-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2012-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078020-003VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2012-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078020-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2012-09-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078020-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2012-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078020-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2012-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078020-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2012-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078020-003VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2012-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078020-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2012-09-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078020-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2012-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078020-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2012-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078020-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2012-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078020-003VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2012-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078020-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2012-09-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078020-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2012-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078020-001VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;80MGTABLET / ORALAB2012-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078020-002VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;160MGTABLET / ORALAB2012-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078020-003VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;160MGTABLET / ORALAB2012-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078020-004VALSARTAN AND HYDROCHLOROTHIAZIDE12.5MG;320MGTABLET / ORALAB2012-09-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078020-005VALSARTAN AND HYDROCHLOROTHIAZIDE25MG;320MGTABLET / ORALAB2012-09-2103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A078020-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A078020-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A078020-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A078020-004AB184e616aacf4f…
2026-09-14 22:38:342026-08A078020-005AB184e616aacf4f…
2026-08-18 06:07:402026-07A078020-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078020-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078020-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078020-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078020-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078020-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078020-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078020-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078020-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078020-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078020-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078020-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078020-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078020-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078020-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078020-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078020-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078020-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078020-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078020-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078020-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078020-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078020-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078020-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078020-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078020-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078020-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078020-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078020-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078020-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078020-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078020-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078020-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078020-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078020-005AB103ed91905a0d…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VALSARTAN320 mg/1
HYDROCHLOROTHIAZIDE25 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
f2b749a6-17ff-e044-e053-2995a90aea28Available 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
51655-243-52Valsartan and Hydrochlorothiazide30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-243VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20240720_f2b749a6-17ff-e044-e053-2995a90aea28.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCf2b749a6-17ff-e044-e053-2995a90aea282026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078020
application number: ANDA078020
ndc (package): 51655-243-52
ndc (product): 51655-243
ndc11 (package): 51655024352
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCf835fa93-6529-c06d-e053-6394a90ad42a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078020
application number: ANDA078020
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEA-S Medication Solutions1b72ecfd-a08d-48c5-a853-d3bc9ff882f12023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078020
application number: ANDA078020
Valsartan and HydrochlorothiazideVALSARTAN AND HYDROCHLOROTHIAZIDEMylan Pharmaceuticals Inc.3ba1f9f9-0037-4522-8605-e27dc8552b5b2023-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078020
application number: ANDA078020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNf2b749a6-17ff-e044-e053-2995a90aea283
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCDf2b749a6-17ff-e044-e053-2995a90aea283
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSYf2b749a6-17ff-e044-e053-2995a90aea283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-243-525165502435230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-243-52) 2022-11-16NoNoCurrent