Irbesartan and Hydrochlorothiazide

Product NDC
68645-405
11-digit product format
686450405
Labeler code
68645
Product ID
68645-405_63e83822-798e-46e0-87bf-45e9d2910184
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging
Application
ANDA077369
Marketing category
ANDA
Marketing start
2012-03-30
Marketing end
0000-00-00
Substance
IRBESARTAN; HYDROCHLOROTHIAZIDE
Active strength
150 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
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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68645-405-70Irbesartan and Hydrochlorothiazide30 in 1 DOSE PACKTABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68645-405-70EA - Each68645-40572aeded1-6163-4c25-b8e8-663bfe451ac212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
IRBESARTANACTIVE INGREDIENTJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
IRBESARTANACTIVE MOIETYJ0E2756Z7NIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-405IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]4Legacy NDC, 1 package rows20121005_2f29f67a-2918-4318-9cb1-5e0eb22b35a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310792irbesartan 150 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN2f29f67a-2918-4318-9cb1-5e0eb22b35a34
310792hydrochlorothiazide 12.5 MG / irbesartan 150 MG Oral TabletSCD2f29f67a-2918-4318-9cb1-5e0eb22b35a34
310792HCTZ 12.5 MG / irbesartan 150 MG Oral TabletSY2f29f67a-2918-4318-9cb1-5e0eb22b35a34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68645-405-706864504057030 in 1 DOSE PACKHistorical