FDA.reportPublic FDA data

Irbesartan and Hydrochlorothiazide

Product NDC
0054-0255
11-digit product format
000540255
Labeler code
0054
Product ID
0054-0255_73e2946e-057a-4748-ac8c-13d48bb36599
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA090351
Marketing category
ANDA
Marketing start
2012-10-15
Substance
HYDROCHLOROTHIAZIDE; IRBESARTAN
Active strength
12.5; 300 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Irbesartan and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCHLOROTHIAZIDE12.5 mg/1
IRBESARTAN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ0E2756Z7N, 0J48LPH2TH
Rxcui310792, 310793, 485471

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
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
34942a29-de4f-d63c-7755-ba18fe1411a0Product name620180619
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-0255-13Irbesartan and Hydrochlorothiazide30 in 1 BOTTLETABLET3021
0054-0255-22Irbesartan and Hydrochlorothiazide90 in 1 BOTTLETABLET9021
0054-0255-29Irbesartan and Hydrochlorothiazide500 in 1 BOTTLETABLET50021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0255-13EA - Each0054-02551975627d-92ea-4eb2-9af8-be4d8f40d37f12013-02-13
0054-0255-22EA - Each0054-0255e7b85ebb-ba14-4a9d-846e-06c9879c506a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
IRBESARTANACTIVE INGREDIENTJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
IRBESARTANACTIVE MOIETYJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [ROXANE LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-0255IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [HIKMA PHARMACEUTICALS USA INC.]17Current NDC, Legacy NDC, 3 package rows20240620_17561aae-f0bc-4ffc-a007-985b17e9baf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN17561aae-f0bc-4ffc-a007-985b17e9baf021
310793irbesartan 300 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN17561aae-f0bc-4ffc-a007-985b17e9baf021
485471irbesartan 300 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN17561aae-f0bc-4ffc-a007-985b17e9baf021
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD17561aae-f0bc-4ffc-a007-985b17e9baf021
310793hydrochlorothiazide 12.5 MG / irbesartan 300 MG Oral TabletSCD17561aae-f0bc-4ffc-a007-985b17e9baf021
485471hydrochlorothiazide 25 MG / irbesartan 300 MG Oral TabletSCD17561aae-f0bc-4ffc-a007-985b17e9baf021
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY17561aae-f0bc-4ffc-a007-985b17e9baf021
310793HCTZ 12.5 MG / irbesartan 300 MG Oral TabletSY17561aae-f0bc-4ffc-a007-985b17e9baf021
485471HCTZ 25 MG / irbesartan 300 MG Oral TabletSY17561aae-f0bc-4ffc-a007-985b17e9baf021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0255-130005402551330 TABLET in 1 BOTTLE (0054-0255-13) 30 tablet2012-10-150000-00-00NoNoCurrent
0054-0255-220005402552290 TABLET in 1 BOTTLE (0054-0255-22) 90 tablet2012-10-150000-00-00NoNoCurrent
0054-0255-2900054025529500 in 1 BOTTLEHistorical