MedPath

Lisinopril

Approved
Approval ID

1979fd2a-7e2b-4d9a-9286-1066a0da944c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 19, 2010

Manufacturers
FDA

State of Florida DOH Central Pharmacy

DUNS: 829348114

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LISINOPRIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53808-0617
Application NumberANDA077622
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification

INGREDIENTS (6)

LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT

LISINOPRIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53808-0700
Application NumberANDA077622
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2010
FDA Product Classification

INGREDIENTS (6)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

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Lisinopril - FDA Drug Approval Details