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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
Bryant Ranch Prepack
DUNS: 171714327
Effective Date
January 19, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Lisinopril(2.5 mg in 1 1)

Manufacturing Establishments1

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

Bryant Ranch Prepack

Bryant Ranch Prepack

171714327

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
71335-1380
Application Number
ANDA076059
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 27, 2018
Code: E7199S1YWRClass: ACTIBQuantity: 2.5 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
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