FDA Product

Lorazepam

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Lorazepam

FDA Product Code

65162-687

Regulatory Information

NDC Product Code

65162-687

Application Number

ANDA091383

Marketing Category

C73584

Effective Date

March 16, 2021

Territorial Authority

USA

FDA Title

Lorazepam Oral Concentrate USP, 2 mg per mL, CIV Rx Only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

17

Company Information

ManufacturerAmneal Pharmaceuticals LLC

DUNS Number

123797875

Active Ingredients

NITROGEN

Code: N762921K75

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

Quantity: 2 mg in 1 mL

Code: O26FZP769L

Class Code: ACTIB

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

Active Moieties

LORAZEPAM

Code: O26FZP769L

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