FDA.reportPublic FDA data

Valsartan and Hydrochlorothiazide

Product NDC
33342-078
11-digit product format
333420078
Labeler code
33342
Product ID
33342-078_a1b947a6-e356-4442-9df7-9e82b299a852
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valsartan and Hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203145
Marketing category
ANDA
Marketing start
2013-04-19
Substance
HYDROCHLOROTHIAZIDE; VALSARTAN
Active strength
25; 320 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

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
VALSARTAN320 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, 80M03YXJ7I
Rxcui200284, 200285, 349353, 636042, 636045

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
33342-078-10Valsartan and Hydrochlorothiazide90 in 1 BOTTLETABLET, FILM COATED908
33342-078-15Valsartan and Hydrochlorothiazide500 in 1 BOTTLETABLET, FILM COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-078-10EA - Each33342-078b8c54fda-3e13-4d50-ac83-aa8ce5903b7612014-07-02
33342-078-15EA - Each33342-0786b473d1c-b898-44d8-960c-ab876e2d72be12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-078VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 2 package rows20221104_771afba6-8769-4ea8-afec-358dba0aaefe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN497223a9-0d53-4f79-b031-07cc5204d80f102
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCD497223a9-0d53-4f79-b031-07cc5204d80f102
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSY497223a9-0d53-4f79-b031-07cc5204d80f102
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletPSN771afba6-8769-4ea8-afec-358dba0aaefe8
200285valsartan 160 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN771afba6-8769-4ea8-afec-358dba0aaefe8
349353valsartan 160 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN771afba6-8769-4ea8-afec-358dba0aaefe8
636042valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN771afba6-8769-4ea8-afec-358dba0aaefe8
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN771afba6-8769-4ea8-afec-358dba0aaefe8
200285hydrochlorothiazide 12.5 MG / valsartan 160 MG Oral TabletSCD771afba6-8769-4ea8-afec-358dba0aaefe8
636042hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral TabletSCD771afba6-8769-4ea8-afec-358dba0aaefe8
200284hydrochlorothiazide 12.5 MG / valsartan 80 MG Oral TabletSCD771afba6-8769-4ea8-afec-358dba0aaefe8
349353hydrochlorothiazide 25 MG / valsartan 160 MG Oral TabletSCD771afba6-8769-4ea8-afec-358dba0aaefe8
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCD771afba6-8769-4ea8-afec-358dba0aaefe8
200285HCTZ 12.5 MG / valsartan 160 MG Oral TabletSY771afba6-8769-4ea8-afec-358dba0aaefe8
636042HCTZ 12.5 MG / valsartan 320 MG Oral TabletSY771afba6-8769-4ea8-afec-358dba0aaefe8
200284HCTZ 12.5 MG / valsartan 80 MG Oral TabletSY771afba6-8769-4ea8-afec-358dba0aaefe8
349353HCTZ 25 MG / valsartan 160 MG Oral TabletSY771afba6-8769-4ea8-afec-358dba0aaefe8
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSY771afba6-8769-4ea8-afec-358dba0aaefe8
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNdb118092-2002-7a55-e053-2a95a90a7b2c4
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCDdb118092-2002-7a55-e053-2a95a90a7b2c4
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSYdb118092-2002-7a55-e053-2a95a90a7b2c4
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNef100fa1-dd63-4287-8543-480a82ace1683
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCDef100fa1-dd63-4287-8543-480a82ace1683
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSYef100fa1-dd63-4287-8543-480a82ace1683
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNd1383a2b-8def-48cc-8b8a-00b8b02365582
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCDd1383a2b-8def-48cc-8b8a-00b8b02365582
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSYd1383a2b-8def-48cc-8b8a-00b8b02365582
636045valsartan 320 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN87b4f655-2327-49e5-887c-35f058241c621
636045hydrochlorothiazide 25 MG / valsartan 320 MG Oral TabletSCD87b4f655-2327-49e5-887c-35f058241c621
636045HCTZ 25 MG / valsartan 320 MG Oral TabletSY87b4f655-2327-49e5-887c-35f058241c621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-078-103334200781090 TABLET, FILM COATED in 1 BOTTLE (33342-078-10) 2013-04-190000-00-00NoNoCurrent
33342-078-1533342007815500 TABLET, FILM COATED in 1 BOTTLE (33342-078-15) 2013-04-190000-00-00NoNoCurrent