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FDA Approval

LISINOPRIL

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Unit Dose Services
DUNS: 831995316
Effective Date
February 27, 2017
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Lisinopril(5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Unit Dose Services

Unit Dose Services

831995316

Products1

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

LISINOPRIL

Product Details

NDC Product Code
50436-0376
Application Number
ANDA202554
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
December 27, 2016
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
Code: E7199S1YWRClass: ACTIBQuantity: 5 mg in 1 1
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