FDA.reportPublic FDA data

Valsartan and Hydrochlorothiazide

Product NDC
0781-5951
11-digit product format
007815951
Labeler code
0781
Product ID
0781-5951_ff7a21b8-e6b1-4111-a48f-143877db39eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
valsartan and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
NDA020818
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-09-21
Marketing end
0000-00-00
Substance
VALSARTAN; HYDROCHLOROTHIAZIDE
Active strength
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0781-5951-102025-11-20C16284748780-19d75b9cf-e258-f424-e053-dadaa90a57cef1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e
0781-5951-372025-11-20C16284748780-19d75b9cf-e258-f424-e053-dadaa90a57cef1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e
0781-5951-642025-11-20C16284748780-19d75b9cf-e258-f424-e053-dadaa90a57cef1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e
0781-5951-922025-11-20C16284748780-19d75b9cf-e258-f424-e053-dadaa90a57cef1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e
0781-5951-102020-01-31C16284748780-19d75b9cf-e258-f424-e053-dadaa90a57cef1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e
0781-5951-372020-01-31C16284748780-19d75b9cf-e258-f424-e053-dadaa90a57cef1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e
0781-5951-642020-01-31C16284748780-19d75b9cf-e258-f424-e053-dadaa90a57cef1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e
0781-5951-922020-01-31C16284748780-19d75b9cf-e258-f424-e053-dadaa90a57cef1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5951-10EA - Each0781-59511160ddad-54ca-4f1b-9724-1615e9b7381512013-02-13
0781-5951-64EA - Each0781-5951f82332da-7344-4172-96ed-66bc8000f75c12013-02-13
0781-5951-92EA - Each0781-5951211c1de6-446b-4943-9be9-f3c2574320ec12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
VALSARTANACTIVE INGREDIENT80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
VALSARTANACTIVE MOIETY80M03YXJ7IVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5951VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [SANDOZ INC]4Legacy NDC20141016_f1a2d5de-3b7f-40c0-a5bd-fd64fac59d7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636042valsartan 320 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN1bace05a-ac18-4bf4-97b3-641ad1e6fd782
636042hydrochlorothiazide 12.5 MG / valsartan 320 MG Oral TabletSCD1bace05a-ac18-4bf4-97b3-641ad1e6fd782
636042HCTZ 12.5 MG / valsartan 320 MG Oral TabletSY1bace05a-ac18-4bf4-97b3-641ad1e6fd782