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Ativan

Lorazepam · Injection

Prescription NDA Schedule CIV TE AP RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Ativan
Generic name
Lorazepam
Dosage form
Injection
Route
Intramuscular
Marketing category
NDA · NDA
Labeler
Hikma Pharmaceuticals USA Inc.
Product type
Human Prescription Drug
DEA schedule
CIV
Active ingredients
2
NDC product codes
4
Packages
4
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Lorazepam 2 mg/mL 197901 View
Lorazepam 4 mg/mL 197901 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection
Route of administration
Intramuscular
Presentations
8

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Benzodiazepine [EPC] EPC All 48 members
Benzodiazepines [CS] CS All 48 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
018140
Application type
NDA · New Drug Application
Approval date
July 25, 1980
Sponsor
HIKMA
Products on application
2
Submissions recorded
36
Products approved under application 018140.
Product Trade name Form Strength Ingredient Status TE Flags
018140-001 ATIVAN INJECTABLE LORAZEPAM Prescription AP RLD RS
018140-002 ATIVAN INJECTABLE LORAZEPAM Prescription AP RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AP
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (parenteral aqueous solutions)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 018140.
Type No. Action Status Date Review
Supplement 51 Labeling Approved January 13, 2023 Standard
Supplement 46 Labeling Approved February 5, 2021 901 Required
Supplement 42 Labeling Approved April 27, 2017 901 Required
Supplement 41 Labeling Approved April 27, 2017 901 Required
Supplement 40 Labeling Approved May 27, 2016 Standard
Supplement 38 Manufacturing (CMC) Approved April 18, 2016 Standard
Supplement 39 Manufacturing (CMC) Approved October 2, 2015 Standard
Supplement 28 Labeling Approved November 29, 2006 Standard
Supplement 27 Labeling Approved December 12, 2001 Standard
Supplement 26 Labeling Approved September 26, 2000 Standard
Supplement 24 Manufacturing (CMC) Approved October 16, 1998 Standard
Supplement 25 Manufacturing (CMC) Approved November 4, 1997 Standard
Supplement 3 Efficacy Approved September 5, 1997 —
Supplement 23 Manufacturing (CMC) Approved September 26, 1996 Standard
Supplement 22 Labeling Approved March 19, 1996 Standard
Supplement 12 Labeling Approved March 19, 1996 —
Supplement 11 Labeling Approved March 19, 1996 —
Supplement 9 Labeling Approved March 19, 1996 —
Supplement 21 Manufacturing (CMC) Approved March 8, 1995 Standard
Supplement 20 Manufacturing (CMC) Approved January 6, 1995 Standard
Supplement 19 Manufacturing (CMC) Approved September 29, 1993 Standard
Supplement 18 Manufacturing (CMC) Approved September 29, 1993 Standard
Supplement 17 Manufacturing (CMC) Approved June 3, 1993 Standard
Supplement 16 Manufacturing (CMC) Approved August 18, 1992 Standard
Supplement 15 Manufacturing (CMC) Approved June 26, 1991 Standard
Supplement 14 Manufacturing (CMC) Approved January 2, 1991 Standard
Supplement 13 Manufacturing (CMC) Approved November 3, 1989 Standard
Supplement 10 Manufacturing (CMC) Approved June 13, 1989 Standard
Supplement 7 Manufacturing (CMC) Approved April 24, 1987 Standard
Supplement 8 Labeling Approved April 13, 1987 —
Supplement 6 Manufacturing (CMC) Approved February 14, 1984 Standard
Supplement 5 Manufacturing (CMC) Approved February 14, 1984 Standard
Supplement 4 Manufacturing (CMC) Approved June 14, 1983 Standard
Supplement 2 Manufacturing (CMC) Approved February 2, 1981 Standard
Supplement 1 Labeling Approved September 9, 1980 —
Original application 1 Type 3 - New Dosage Form Approved July 25, 1980 Standard

Review documents

  • 0 · Supplement · January 17, 2023
  • 0 · Supplement · January 17, 2023
  • 0 · Supplement · February 9, 2021
  • 0 · Supplement · February 9, 2021
  • 0 · Supplement · May 2, 2017
  • 0 · Supplement · May 2, 2017
  • 0 · Supplement · May 2, 2017
  • 0 · Supplement · May 2, 2017
  • 0 · Supplement · February 15, 2017
  • 0 · Supplement · May 31, 2016
  • 0 · Supplement · April 9, 2007
  • 0 · Supplement · December 28, 2006
  • 0 · Supplement · December 4, 2006
  • 0 · Supplement · October 5, 1997

Adverse event reports

Source: openFDA FAERS
178,719
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LORAZEPAM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0641-6000-10 0641-6000 Hikma Pharmaceuticals USA Inc. 10 VIAL in 1 CARTON (0641-6000-10) / 10 mL in 1 VIAL (0641-6000-01) July 25, 1980
0641-6001-25 0641-6001 Hikma Pharmaceuticals USA Inc. 25 VIAL in 1 CARTON (0641-6001-25) / 1 mL in 1 VIAL (0641-6001-01) July 25, 1980
0641-6002-10 0641-6002 Hikma Pharmaceuticals USA Inc. 10 VIAL in 1 CARTON (0641-6002-10) / 10 mL in 1 VIAL (0641-6002-01) July 25, 1980
0641-6003-25 0641-6003 Hikma Pharmaceuticals USA Inc. 25 VIAL in 1 CARTON (0641-6003-25) / 1 mL in 1 VIAL (0641-6003-01) July 25, 1980
0641-6000 0641-6000 Hikma Pharmaceuticals USA Inc. — July 25, 1980
0641-6001 0641-6001 Hikma Pharmaceuticals USA Inc. — July 25, 1980
0641-6002 0641-6002 Hikma Pharmaceuticals USA Inc. — July 25, 1980
0641-6003 0641-6003 Hikma Pharmaceuticals USA Inc. — July 25, 1980

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.