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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
Effective Date
September 18, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Lisinopril(20 mg in 1 1)

Manufacturing Establishments1

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

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

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
68071-3409
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
September 18, 2023
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Code: E7199S1YWRClass: ACTIBQuantity: 20 mg in 1 1
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