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Lisinopril

LISINOPRIL TABLETS USP - PACKAGE LABELS

Approved
Approval ID

9b73c97f-b898-471f-be8a-96324a3e3b86

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 29, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

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 Code21695-345
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateNovember 12, 2009
FDA Product Classification

INGREDIENTS (6)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LISINOPRILActive
Quantity: 2.5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT

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Lisinopril - FDA Drug Approval Details