Lisinopril and Hydrochlorothiazide

Product NDC
63304-536
11-digit product format
633040536
Labeler code
63304
Product ID
63304-536_b119c7cd-d261-41ca-94a4-d01ace9e4929
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lisinopril and hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA076007
Marketing category
ANDA
Marketing start
2002-07-02
Marketing end
0000-00-00
Substance
LISINOPRIL; HYDROCHLOROTHIAZIDE
Active strength
10 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
E
Listing certified through
2018-12-31
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
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
63304-536-012020-01-31C16284748780-19d75b9d0-fa66-f424-e053-dadaa90a57ceLISINOPRIL and HYDROCHLOROTHIAZIDE TABLETS, USP
63304-536-052020-01-31C16284748780-19d75b9d0-fa66-f424-e053-dadaa90a57ceLISINOPRIL and HYDROCHLOROTHIAZIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-536-01Lisinopril and Hydrochlorothiazide100 in 1 BOTTLETABLET1006
63304-536-05Lisinopril and Hydrochlorothiazide500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-536-01EA - Each63304-5362efb31e3-ae4b-471e-8c3a-9b2156e46fb012013-02-13
63304-536-05EA - Each63304-53642c33858-413a-421e-a3d4-fbb242ff21d512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
LISINOPRIL ANHYDROUSACTIVE MOIETY7Q3P4BS2FDLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5
LISINOPRILACTIVE INGREDIENTE7199S1YWRLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5
LISINOPRILACTIVE MOIETYE7199S1YWRLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ALISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [PHYSICIANS TOTAL CARE, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-536LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLET [RANBAXY PHARMACEUTICALS INC.]6Legacy NDC, 2 package rows20131226_b8f4d730-fd8e-4692-aabd-e2b7e63fabe1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197885lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNb8f4d730-fd8e-4692-aabd-e2b7e63fabe16
197886lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSNb8f4d730-fd8e-4692-aabd-e2b7e63fabe16
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNb8f4d730-fd8e-4692-aabd-e2b7e63fabe16
197885hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral TabletSCDb8f4d730-fd8e-4692-aabd-e2b7e63fabe16
197886hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral TabletSCDb8f4d730-fd8e-4692-aabd-e2b7e63fabe16
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCDb8f4d730-fd8e-4692-aabd-e2b7e63fabe16
197885HCTZ 12.5 MG / lisinopril 10 MG Oral TabletSYb8f4d730-fd8e-4692-aabd-e2b7e63fabe16
197886HCTZ 12.5 MG / lisinopril 20 MG Oral TabletSYb8f4d730-fd8e-4692-aabd-e2b7e63fabe16
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSYb8f4d730-fd8e-4692-aabd-e2b7e63fabe16
197885lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN4700340f-4f77-48f2-bef2-bf6391bc25da5
197886lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN4700340f-4f77-48f2-bef2-bf6391bc25da5
197887lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN4700340f-4f77-48f2-bef2-bf6391bc25da5
197885hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral TabletSCD4700340f-4f77-48f2-bef2-bf6391bc25da5
197886hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral TabletSCD4700340f-4f77-48f2-bef2-bf6391bc25da5
197887hydrochlorothiazide 25 MG / lisinopril 20 MG Oral TabletSCD4700340f-4f77-48f2-bef2-bf6391bc25da5
197885HCTZ 12.5 MG / lisinopril 10 MG Oral TabletSY4700340f-4f77-48f2-bef2-bf6391bc25da5
197886HCTZ 12.5 MG / lisinopril 20 MG Oral TabletSY4700340f-4f77-48f2-bef2-bf6391bc25da5
197887HCTZ 25 MG / lisinopril 20 MG Oral TabletSY4700340f-4f77-48f2-bef2-bf6391bc25da5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-536-0163304053601100 in 1 BOTTLEHistorical
63304-536-0563304053605500 in 1 BOTTLEHistorical