LISINOPRIL AND HYDROCHLOROTHIAZIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg
Approved
Approval ID
7cd68095-12a7-446d-8ee6-4301cdf3f934
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2010
Manufacturers
FDA
Blenheim Pharmacal, Inc.
DUNS: 171434587
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 Code10544-564
Application NumberANDA077912
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 6, 2010
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT