MedPath

Lorazepam

Lorazepam Tablets, USP CIV 924 958 936 Rx only

Approved
Approval ID

59278102-8ac3-5fd2-e053-2991aa0a5ce2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 14, 2017

Manufacturers
FDA

Contract Pharmacy Services-PA

DUNS: 945429777

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 Code67046-924
Application NumberANDA078203
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2017
FDA Product Classification

INGREDIENTS (5)

LORAZEPAMActive
Quantity: 0.5 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Lorazepam - FDA Drug Approval Details