Quinapril Tablets, Usp

Quinapril Tablets, Usp
SPL v5
SPL
SPL Set ID e6d36e1e-8e35-4d06-83dc-45e0456365fd
Route
ORAL
Published
Effective Date 2020-05-25
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Lactose Monohydrate Magnesium Carbonate Magnesium Stearate Crospovidone, Unspecified Povidone, Unspecified Hypromellose, Unspecified Titanium Dioxide Ferric Oxide Red Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: IG;270 Shape: round Shape: oval Color: brown Size: 6 mm Size: 8 mm Size: 14 mm Score: 1
Marketing Status
ANDA Active Since 2016-07-22

Description

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue quinapril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity


Medication Information

Recent Major Changes

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue quinapril as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity
Description

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue quinapril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity

Section 42229-5

Quinapril hydrochloride, USP is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.

Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 •HCl and its structural formula is:

Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents.

Quinapril tablets, USP contain quinapril hydrochloride equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains lactose monohydrate, magnesium carbonate, magnesium stearate, crospovidone, povidone and opadry brown (hypromellose, titanium dioxide, iron oxide and macrogol).

Package Label.principal Display Panel

NDC 69097-839-05  Rx Only

Quinapril Tablets, USP

5 mg*

90 Tablets

Cipla

NDC 69097-841-05  Rx Only

Quinapril Tablets, USP

10 mg*

90 Tablets

Cipla

NDC 69097-842-05  Rx Only

Quinapril Tablets, USP

20 mg*

90 Tablets

Cipla

NDC 69097-843-05  Rx Only

Quinapril Tablets, USP

40 mg*

90 Tablets

Cipla




Structured Label Content

Recent Major Changes (34066-1)

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue quinapril as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity
Section 42229-5 (42229-5)

Quinapril hydrochloride, USP is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat.

Quinapril hydrochloride, USP is chemically described as [3S-[2[R*(R*)], 3R*]]-2-[2-[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic acid, monohydrochloride. Its empirical formula is C25H30N2O5 •HCl and its structural formula is:

Quinapril hydrochloride, USP is a white to off-white amorphous powder that is freely soluble in aqueous solvents.

Quinapril tablets, USP contain quinapril hydrochloride equivalent to 5 mg, 10 mg, 20 mg, or 40 mg of quinapril for oral administration. Each tablet also contains lactose monohydrate, magnesium carbonate, magnesium stearate, crospovidone, povidone and opadry brown (hypromellose, titanium dioxide, iron oxide and macrogol).

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 69097-839-05  Rx Only

Quinapril Tablets, USP

5 mg*

90 Tablets

Cipla

NDC 69097-841-05  Rx Only

Quinapril Tablets, USP

10 mg*

90 Tablets

Cipla

NDC 69097-842-05  Rx Only

Quinapril Tablets, USP

20 mg*

90 Tablets

Cipla

NDC 69097-843-05  Rx Only

Quinapril Tablets, USP

40 mg*

90 Tablets

Cipla




Advanced Ingredient Data


Raw Label Data

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