Lisinopril and Hydrochlorothiazide

Product NDC
54458-991
11-digit product format
544580991
Labeler code
54458
Product ID
54458-991_c7b3ecfb-9e7c-4d67-8c6c-b67489400b02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA077912
Marketing category
ANDA
Marketing start
2007-12-15
Marketing end
0000-00-00
Substance
LISINOPRIL; HYDROCHLOROTHIAZIDE
Active strength
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54458-991-10Lisinopril and Hydrochlorothiazide30 in 1 BLISTER PACKTABLET3034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-991-10EA - Each54458-991ca981f14-4a86-430e-acf3-cb3e4bffc93812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, INC.]28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-991LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [INTERNATIONAL LABORATORIES, LLC]34Legacy NDC, 1 package rows20191219_6414f16f-c3e0-4ca1-ad58-ed081a9c0b09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197885lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN6414f16f-c3e0-4ca1-ad58-ed081a9c0b0934
197886lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN6414f16f-c3e0-4ca1-ad58-ed081a9c0b0934
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN6414f16f-c3e0-4ca1-ad58-ed081a9c0b0934
197885hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral TabletSCD6414f16f-c3e0-4ca1-ad58-ed081a9c0b0934
197886hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral TabletSCD6414f16f-c3e0-4ca1-ad58-ed081a9c0b0934
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCD6414f16f-c3e0-4ca1-ad58-ed081a9c0b0934
197885HCTZ 12.5 MG / lisinopril 10 MG Oral TabletSY6414f16f-c3e0-4ca1-ad58-ed081a9c0b0934
197886HCTZ 12.5 MG / lisinopril 20 MG Oral TabletSY6414f16f-c3e0-4ca1-ad58-ed081a9c0b0934
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSY6414f16f-c3e0-4ca1-ad58-ed081a9c0b0934

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-991-105445809911030 in 1 BLISTER PACKHistorical