temazepam

Product NDC
63187-497
11-digit product format
631870497
Labeler code
63187
Product ID
63187-497_f2a9b002-a1ee-49e1-8477-0eb89fdbf1de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA071457
Marketing category
ANDA
Marketing start
1987-04-21
Substance
TEMAZEPAM
Active strength
30 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
CHB1QD2QSSTEMAZEPAM846-50-4TEMAZEPAM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63187-497-0063187049700100 CAPSULE in 1 BOTTLE (63187-497-00) 100 capsule2019-01-01NoNoHistorical
63187-497-306318704973030 CAPSULE in 1 BOTTLE (63187-497-30) 30 capsule2019-01-01NoNoHistorical
63187-497-606318704976060 CAPSULE in 1 BOTTLE (63187-497-60) 60 capsule2019-01-01NoNoHistorical
63187-497-906318704979090 CAPSULE in 1 BOTTLE (63187-497-90) 90 capsule2019-01-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
temazepam - Proficient Rx LPProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL3