MedPath

Lorazepam

Lorazepam Tablets, USP CIV Rx only

Approved
Approval ID

0cd02e52-ead5-4b2a-9708-c7c4be7b7995

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 4, 2024

Manufacturers
FDA

REMEDYREPACK INC.

DUNS: 829572556

Products 1

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

Lorazepam

PRODUCT DETAILS

NDC Product Code70518-0275
Application NumberANDA078203
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 4, 2024
Generic NameLorazepam

INGREDIENTS (5)

LORAZEPAMActive
Quantity: 1 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/28/2023

DRUG: Lorazepam

GENERIC: Lorazepam

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0275-0

NDC: 70518-0275-1

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 7 mm

IMPRINT: EP;905;1

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 60 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • LORAZEPAM 1mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • MAGNESIUM STEARATE
  • CELLULOSE, MICROCRYSTALLINE
  • POLACRILIN POTASSIUM

MM1

DESCRIPTION SECTION

LOINC: 34089-3Updated: 12/28/2023

DESCRIPTION

Lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-( o-chlorophenyl)-1,3-dihydro-3-hydroxy-2 H-1,4-benzodiazepin-2-one:

![Lorazepam structure](/dailymed/image.cfm?name=lorazepam- structure.jpg&id=877304)

It is a nearly white powder almost insoluble in water. Each Lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose anhydrous, magnesium stearate, microcrystalline cellulose, and polacrilin potassium.

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