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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
Effective Date
June 7, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Hydrochlorothiazide(12.5 mg in 1 1)
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.

RPK Pharmaceuticals, Inc.

RPK Pharmaceuticals, Inc.

147096275

Products1

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
53002-1674
Application Number
ANDA077912
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 9, 2021
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1
Code: E7199S1YWRClass: ACTIBQuantity: 20 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

CONTRAINDICATIONS SECTION

CONTRAINDICATIONS

Lisinopril and hydrochlorothiazide is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Lisinopril and hydrochlorothiazide is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lisinopril and Hydrochlorothiazide tablets USP within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (seeWARNINGS).

Do not co-administer aliskiren with lisinopril and hydrochlorothiazide in patients with diabetes (seePRECAUTIONS, Drug Interactions).


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