FDA.reportPublic FDA data

HYZAAR

Product NDC
0006-0717
11-digit product format
000060717
Labeler code
0006
Product ID
0006-0717_3360bde2-aee8-4fc5-b7e0-2cd410edb079
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
losartan potassium and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Merck Sharp & Dohme Corp.
Application
NDA020387
Marketing category
NDA
Marketing start
1995-04-28
Marketing end
0000-00-00
Substance
LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
Active strength
50 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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
0d341e63-aee5-498b-bf9a-b53a43963acfProduct name120260105
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
de29c5c0-90ba-29da-d7ab-0500274708beProduct name620241009
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0006-0717-312021-09-15C16284748780-1c7ccaba7-1890-fd44-e053-dadaa90aa01bd3e434b9-2f56-4dec-8cbf-a61e23abcc6a
0006-0717-542021-09-15C16284748780-1c7ccaba7-1890-fd44-e053-dadaa90aa01bd3e434b9-2f56-4dec-8cbf-a61e23abcc6a
0006-0717-822021-09-15C16284748780-1c7ccaba7-1890-fd44-e053-dadaa90aa01bd3e434b9-2f56-4dec-8cbf-a61e23abcc6a
0006-0717-312021-07-23C16284748780-1c7ccaba7-1890-fd44-e053-dadaa90aa01bd3e434b9-2f56-4dec-8cbf-a61e23abcc6a
0006-0717-542021-07-23C16284748780-1c7ccaba7-1890-fd44-e053-dadaa90aa01bd3e434b9-2f56-4dec-8cbf-a61e23abcc6a
0006-0717-822021-07-23C16284748780-1c7ccaba7-1890-fd44-e053-dadaa90aa01bd3e434b9-2f56-4dec-8cbf-a61e23abcc6a

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0717-28EA - Each0006-07175020394b-b52d-409f-9177-3c329c80707712013-02-11
0006-0717-31EA - Each0006-07177fb35d44-08cb-4df3-bbcd-6f54c8ef3d5512012-07-24
0006-0717-54EA - Each0006-07170f799034-057d-49d5-af2f-320acacfd46e12012-07-24
0006-0717-82EA - Each0006-07171c32fcad-c818-4758-9168-fac75a76e6ab12012-07-24
0006-0717-86EA - Each0006-07177d166525-fff6-4929-bcd9-09e72888b53312013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
losartan potassiumACTIVE INGREDIENT3ST302B24AHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
hydrochlorothiazideACTIVE MOIETY0J48LPH2THHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
losartanACTIVE MOIETYJMS50MPO89HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
hydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
losartan potassiumACTIVE INGREDIENT3ST302B24AHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
hydrochlorothiazideACTIVE MOIETY0J48LPH2THHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
losartanACTIVE MOIETYJMS50MPO89HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
hydroxypropyl cellulose (type H)INACTIVE INGREDIENTRFW2ET671PHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30HYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPHYZAAR (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979466Hyzaar 100 MG / 12.5 MG Oral TabletPSNd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979473Hyzaar 100 MG / 25 MG Oral TabletPSNd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979470Hyzaar 50 MG / 12.5 MG Oral TabletPSNd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979464losartan potassium 100 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979471losartan potassium 100 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979466hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral Tablet [Hyzaar]SBDd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979470hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral Tablet [Hyzaar]SBDd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979473hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral Tablet [Hyzaar]SBDd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979464hydrochlorothiazide 12.5 MG / losartan potassium 100 MG Oral TabletSCDd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCDd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979471hydrochlorothiazide 25 MG / losartan potassium 100 MG Oral TabletSCDd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979464HCTZ 12.5 MG / Losartan K+ 100 MG Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979466HCTZ 12.5 MG / Losartan K+ 100 MG Oral Tablet [Hyzaar]SYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979470HCTZ 12.5 MG / Losartan K+ 50 MG Oral Tablet [Hyzaar]SYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979464HCTZ 12.5 MG / Losartan Pot 100 MG Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979466HCTZ 12.5 MG / Losartan Pot 100 MG Oral Tablet [Hyzaar]SYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979470HCTZ 12.5 MG / Losartan Pot 50 MG Oral Tablet [Hyzaar]SYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979464HCTZ 12.5 MG / losartan potassium 100 MG Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979471HCTZ 25 MG / Losartan K+ 100 MG Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979473HCTZ 25 MG / Losartan K+ 100 MG Oral Tablet [Hyzaar]SYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979471HCTZ 25 MG / Losartan Pot 100 MG Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979473HCTZ 25 MG / Losartan Pot 100 MG Oral Tablet [Hyzaar]SYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979471HCTZ 25 MG / losartan potassium 100 MG Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979466Hyzaar 100/12.5 Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979473Hyzaar 100/25 (hydrochlorothiazide 25 MG / losartan potassium 100 MG) Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979473Hyzaar 100/25 Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979470Hyzaar 50/12.5 (hydrochlorothiazide 12.5 MG / losartan potassium 50 MG) Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979470Hyzaar 50/12.5 Oral TabletSYd7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab3
979470Hyzaar 50 MG / 12.5 MG Oral TabletPSNb82d5bbc-2ead-4060-a37d-7cffb0d874231
979468losartan potassium 50 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNb82d5bbc-2ead-4060-a37d-7cffb0d874231
979470hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral Tablet [Hyzaar]SBDb82d5bbc-2ead-4060-a37d-7cffb0d874231
979468hydrochlorothiazide 12.5 MG / losartan potassium 50 MG Oral TabletSCDb82d5bbc-2ead-4060-a37d-7cffb0d874231
979468HCTZ 12.5 MG / Losartan K+ 50 MG Oral TabletSYb82d5bbc-2ead-4060-a37d-7cffb0d874231
979470HCTZ 12.5 MG / Losartan K+ 50 MG Oral Tablet [Hyzaar]SYb82d5bbc-2ead-4060-a37d-7cffb0d874231
979468HCTZ 12.5 MG / Losartan Pot 50 MG Oral TabletSYb82d5bbc-2ead-4060-a37d-7cffb0d874231
979470HCTZ 12.5 MG / Losartan Pot 50 MG Oral Tablet [Hyzaar]SYb82d5bbc-2ead-4060-a37d-7cffb0d874231
979470Hyzaar 50/12.5 (hydrochlorothiazide 12.5 MG / losartan potassium 50 MG) Oral TabletSYb82d5bbc-2ead-4060-a37d-7cffb0d874231
979470Hyzaar 50/12.5 Oral TabletSYb82d5bbc-2ead-4060-a37d-7cffb0d874231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0006-0717-310000607173130 TABLET, FILM COATED in 1 BOTTLE (0006-0717-31) 1995-04-280000-00-00NoNoCurrent
0006-0717-540000607175490 TABLET, FILM COATED in 1 BOTTLE (0006-0717-54) 1995-04-280000-00-00NoNoCurrent
0006-0717-82000060717821000 TABLET, FILM COATED in 1 BOTTLE (0006-0717-82) 1995-04-280000-00-00NoNoCurrent