Lisinopril and Hydrochlorothiazide
LISINOPRIL and HYDROCHLOROTHIAZIDE TABLETS USP Rx only
Approved
Approval ID
0e7e3947-be0e-4407-a424-a365f99f4350
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 7, 2012
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lisinopril and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66116-300
Application NumberANDA075776
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 7, 2012
FDA Product Classification
INGREDIENTS (9)
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT