Irbesartan and Hydrochlorothiazide
These highlights do not include all the information needed to use Irbesartan and Hydrochlorothiazide Tablets USP safely and effectively. See full prescribing information for Irbesartan and Hydrochlorothiazide Tablets USP. Irbesartan and Hydrochlorothiazide Tablets, USP Initial U.S. Approval: 1997
Approved
Approval ID
f5b37c13-e10c-4623-aac5-9a6512b2f701
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 7, 2015
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Irbesartan and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6457
Application NumberANDA202414
Product Classification
M
Marketing Category
C73584
G
Generic Name
Irbesartan and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2015
FDA Product Classification
INGREDIENTS (14)
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
IRBESARTANActive
Quantity: 150 mg in 1 1
Code: J0E2756Z7N
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 3000Inactive
Code: SA1B764746
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
CARBOXYMETHYLCELLULOSE CALCIUMInactive
Code: UTY7PDF93L
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT