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Lisinopril and Hydrochlorothiazide

LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP

Approved
Approval ID

1b8ac4ae-8f0d-43a2-97b8-3c3c6a406d8d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 7, 2023

Manufacturers
FDA

RPK Pharmaceuticals, Inc.

DUNS: 147096275

Products 1

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

Lisinopril and Hydrochlorothiazide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53002-1674
Application NumberANDA077912
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2021
FDA Product Classification

INGREDIENTS (7)

HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT

Drug Labeling Information

CONTRAINDICATIONS SECTION

LOINC: 34070-3Updated: 10/1/2017

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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Lisinopril and Hydrochlorothiazide - FDA Drug Approval Details