Skip to content
LookupMeds

Active ingredient

Temazepam

88 finished FDA listings contain Temazepam as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
TEMAZEPAM
Dosage forms
Capsule
Routes
Oral
Manufacturers / labelers
22
Strengths listed
15 mg/1 · 22.5 mg/1 · 30 mg/1 · 7.5 mg/1
Brand names in FDA listings
Restoril, Temazepam

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 10355

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 018163SPECGX LLC1981-02-2713
ANDA 071456NOVEL LABS INC1987-04-2117
ANDA 071457NOVEL LABS INC1987-04-2127
ANDA 071620ACTAVIS ELIZABETH1987-08-075
ANDA 201781PRINSTON INC2015-06-044
ANDA 203482AMNEAL PHARMS2016-05-237
ANDA 211542ALEMBIC2018-11-2314

Official labeling on DailyMed

Showing the 12 most recent of 55 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.