Lisinopril and hydrochlorothiazide
Lisinopril and Hydrochlorothiazide Tablets Rx only
Approved
Approval ID
2937de2e-8c86-4248-917a-589b092e95ea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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 Code53808-0452
Application NumberANDA078402
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2010
FDA Product Classification
INGREDIENTS (7)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LISINOPRILActive
Quantity: 5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT