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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70518-0275
Application NumberANDA078203
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2024
FDA Product Classification

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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