Lisinopril and Hydrochlorothiazide
Lisinopril and Hydrochlorothiazide Tablets, USP, for oral use Rx Only
Approved
Approval ID
00b266d9-ac4a-e931-e063-6294a90a6a0b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 29, 2023
Manufacturers
FDA
ST. MARY'S MEDICAL PARK PHARMACY
DUNS: 063050751
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lisinopril and Hydrochlorothiazide Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60760-586
Application NumberANDA076230
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril and Hydrochlorothiazide Tablets
Product Specifications
Route of AdministrationORAL
Effective DateJune 29, 2023
FDA Product Classification
INGREDIENTS (6)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT