FDA.reportPublic FDA data

Zestoretic

Product NDC
52427-437
11-digit product format
524270437
Labeler code
52427
Product ID
52427-437_b8a81227-c1af-6093-4d92-647ad3fee155
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lisinopril and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Almatica Pharma Inc.
Application
NDA019888
Marketing category
NDA
Marketing start
2015-04-15
Substance
HYDROCHLOROTHIAZIDE; LISINOPRIL
Active strength
25; 20 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], 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
Zestoretic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE25 mg/1
LISINOPRIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0J48LPH2TH, E7199S1YWR
Rxcui197885, 197886, 197887, 823971, 823982, 823986

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
f8f05a6d-f74b-4e9e-ab1c-374d3b4fb820Product name120230703
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
f65307a7-3644-0a09-cdfd-94aae8d3b53eProduct name320210902
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product 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
52427-437-902020-07-22C16284748780-1ab0e2407-2944-f274-e053-dbdaa90a64710d3a966f-f937-05a8-a90f-5aa52ebbd613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52427-437-90Zestoretic90 in 1 BOTTLETABLET9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52427-437-90EA - Each52427-437cec71925-3670-46f3-8207-54f72d597fd912015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4
LISINOPRILACTIVE INGREDIENTE7199S1YWRZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52427-437ZESTORETIC (LISINOPRIL AND HYDROCHLOROTHIAZIDE) TABLET [ALMATICA PHARMA INC.]15Current NDC, Legacy NDC, 1 package rows20241012_0d3a966f-f937-05a8-a90f-5aa52ebbd613.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197885lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN0d3a966f-f937-05a8-a90f-5aa52ebbd61316
197886lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN0d3a966f-f937-05a8-a90f-5aa52ebbd61316
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823986Zestoretic 10 MG / 12.5 MG Oral TabletPSN0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823982Zestoretic 20 MG / 12.5 MG Oral TabletPSN0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823971Zestoretic 20 MG / 25 MG Oral TabletPSN0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823986hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral Tablet [Zestoretic]SBD0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823982hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet [Zestoretic]SBD0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823971hydrochlorothiazide 25 MG / lisinopril 20 MG Oral Tablet [Zestoretic]SBD0d3a966f-f937-05a8-a90f-5aa52ebbd61316
197885hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral TabletSCD0d3a966f-f937-05a8-a90f-5aa52ebbd61316
197886hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral TabletSCD0d3a966f-f937-05a8-a90f-5aa52ebbd61316
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCD0d3a966f-f937-05a8-a90f-5aa52ebbd61316
197885HCTZ 12.5 MG / lisinopril 10 MG Oral TabletSY0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823986HCTZ 12.5 MG / Lisinopril 10 MG Oral Tablet [Zestoretic]SY0d3a966f-f937-05a8-a90f-5aa52ebbd61316
197886HCTZ 12.5 MG / lisinopril 20 MG Oral TabletSY0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823982HCTZ 12.5 MG / Lisinopril 20 MG Oral Tablet [Zestoretic]SY0d3a966f-f937-05a8-a90f-5aa52ebbd61316
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSY0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823971HCTZ 25 MG / Lisinopril 20 MG Oral Tablet [Zestoretic]SY0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823986Zestoretic 10/12.5 Oral TabletSY0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823982Zestoretic 20/12.5 Oral TabletSY0d3a966f-f937-05a8-a90f-5aa52ebbd61316
823971Zestoretic 20/25 Oral TabletSY0d3a966f-f937-05a8-a90f-5aa52ebbd61316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52427-437-905242704379090 TABLET in 1 BOTTLE (52427-437-90) 90 tablet2015-04-150000-00-00NoNoCurrent