FDA.reportPublic FDA data

Lisinopril and Hydrochlorothiazide

Product NDC
76282-447
11-digit product format
762820447
Labeler code
76282
Product ID
76282-447_7f4a4f31-58b0-4fe1-bd11-ba5a6ac4f26c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and Hydrochlorothiazide Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA204058
Marketing category
ANDA
Marketing start
2019-05-01
Substance
HYDROCHLOROTHIAZIDE; LISINOPRIL
Active strength
12.5; 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
Lisinopril and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
LISINOPRIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiE7199S1YWR, 0J48LPH2TH
Rxcui197885, 197886, 197887

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76282-447-012023-03-28C16284748780-1f386c64a-3839-0266-e053-dadaa90a7c1aLisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-447-052023-03-28C16284748780-1f386c64a-3839-0266-e053-dadaa90a7c1aLisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-447-102023-03-28C16284748780-1f386c64a-3839-0266-e053-dadaa90a7c1aLisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-447-902023-03-28C16284748780-1f386c64a-3839-0266-e053-dadaa90a7c1aLisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-447-012023-01-30C16284748780-1f386c64a-3839-0266-e053-dadaa90a7c1aLisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-447-052023-01-30C16284748780-1f386c64a-3839-0266-e053-dadaa90a7c1aLisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-447-102023-01-30C16284748780-1f386c64a-3839-0266-e053-dadaa90a7c1aLisinopril and Hydrochlorothiazide Tablets, USP Rx Only
76282-447-902023-01-30C16284748780-1f386c64a-3839-0266-e053-dadaa90a7c1aLisinopril and Hydrochlorothiazide Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-447-01Lisinopril and Hydrochlorothiazide100 in 1 BOTTLETABLET1004
76282-447-05Lisinopril and Hydrochlorothiazide500 in 1 BOTTLETABLET5004
76282-447-10Lisinopril and Hydrochlorothiazide1000 in 1 BOTTLETABLET10004
76282-447-90Lisinopril and Hydrochlorothiazide90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-447-01EA - Each76282-447a3f0d4e5-a0ff-46c8-b019-a33ea6892c8912019-09-05
76282-447-05EA - Each76282-447465f7326-8359-4467-b74f-929631f91e6b12019-09-05
76282-447-10EA - Each76282-447814a3da1-9be1-4c59-91bf-a31da5087f8912019-09-05
76282-447-90EA - Each76282-447020fe778-63eb-49e3-89ac-904775f588da12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-447LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS) TABLET [EXELAN PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 4 package rows20230329_c40b15ec-6083-4778-bca8-3e895e5694e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197885lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc40b15ec-6083-4778-bca8-3e895e5694e14
197886lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNc40b15ec-6083-4778-bca8-3e895e5694e14
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNc40b15ec-6083-4778-bca8-3e895e5694e14
197885hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral TabletSCDc40b15ec-6083-4778-bca8-3e895e5694e14
197886hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral TabletSCDc40b15ec-6083-4778-bca8-3e895e5694e14
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCDc40b15ec-6083-4778-bca8-3e895e5694e14
197885HCTZ 12.5 MG / lisinopril 10 MG Oral TabletSYc40b15ec-6083-4778-bca8-3e895e5694e14
197886HCTZ 12.5 MG / lisinopril 20 MG Oral TabletSYc40b15ec-6083-4778-bca8-3e895e5694e14
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSYc40b15ec-6083-4778-bca8-3e895e5694e14
197885lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe2903227-4a79-4a9c-b96b-073b8e41fb011
197886lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNe2903227-4a79-4a9c-b96b-073b8e41fb011
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNe2903227-4a79-4a9c-b96b-073b8e41fb011
197885hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral TabletSCDe2903227-4a79-4a9c-b96b-073b8e41fb011
197886hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral TabletSCDe2903227-4a79-4a9c-b96b-073b8e41fb011
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCDe2903227-4a79-4a9c-b96b-073b8e41fb011
197885HCTZ 12.5 MG / lisinopril 10 MG Oral TabletSYe2903227-4a79-4a9c-b96b-073b8e41fb011
197886HCTZ 12.5 MG / lisinopril 20 MG Oral TabletSYe2903227-4a79-4a9c-b96b-073b8e41fb011
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSYe2903227-4a79-4a9c-b96b-073b8e41fb011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-447-0176282044701100 TABLET in 1 BOTTLE (76282-447-01) 100 tablet2019-05-010000-00-00NoNoCurrent
76282-447-0576282044705500 TABLET in 1 BOTTLE (76282-447-05) 500 tablet2019-05-010000-00-00NoNoCurrent
76282-447-10762820447101000 TABLET in 1 BOTTLE (76282-447-10) 1000 tablet2019-05-010000-00-00NoNoCurrent
76282-447-907628204479090 TABLET in 1 BOTTLE (76282-447-90) 90 tablet2019-05-010000-00-00NoNoCurrent