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FDA Approval

Lisinopril and Hydrochlorothiazide

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

FDA Approval Summary

Company
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
Effective Date
May 28, 2014
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Lisinopril(20 mg in 1 1)
Hydrochlorothiazide(12.5 mg in 1 1)

Manufacturing Establishments1

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

Aphena Pharma Solutions - Tennessee, LLC

Aphena Pharma Solutions - Tennessee, LLC

128385585

Products3

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

Lisinopril and Hydrochlorothiazide

Product Details

NDC Product Code
43353-865
Application Number
ANDA076262
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 28, 2014
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 20 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT

Lisinopril and Hydrochlorothiazide

Product Details

NDC Product Code
43353-867
Application Number
ANDA076262
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 28, 2014
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 20 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT

Lisinopril and Hydrochlorothiazide

Product Details

NDC Product Code
43353-866
Application Number
ANDA076262
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
May 28, 2014
LisinoprilActive
Code: E7199S1YWRClass: ACTIBQuantity: 10 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
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