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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
Proficient Rx LP
DUNS: 079196022
Effective Date
November 1, 2019
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.

Proficient Rx LP

Proficient Rx LP

079196022

Products3

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
63187-257
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 1, 2018
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
Code: E7199S1YWRClass: ACTIBQuantity: 20 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT

Lisinopril

Product Details

NDC Product Code
63187-237
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 1, 2018
Code: E7199S1YWRClass: ACTIBQuantity: 40 mg in 1 1
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

Lisinopril

Product Details

NDC Product Code
63187-098
Application Number
ANDA077321
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 1, 2018
Code: E7199S1YWRClass: ACTIBQuantity: 10 mg in 1 1
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
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