TEMAZEPAM

Product NDC
71610-626
11-digit product format
716100626
Labeler code
71610
Product ID
71610-626_1b2a670e-edfd-4ce9-e063-6294a90aaf23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA018163
Marketing category
NDA
Marketing start
2010-02-23
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
71610-626-157161006261515 CAPSULE in 1 BOTTLE (71610-626-15) 15 capsule2021-12-10NoNoHistorical
71610-626-287161006262828 CAPSULE in 1 BOTTLE (71610-626-28) 28 capsule2024-03-07NoNoHistorical
71610-626-307161006263030 CAPSULE in 1 BOTTLE (71610-626-30) 30 capsule2021-12-10NoNoHistorical
71610-626-537161006265360 CAPSULE in 1 BOTTLE (71610-626-53) 60 capsule2021-12-10NoNoHistorical
71610-626-607161006266090 CAPSULE in 1 BOTTLE (71610-626-60) 90 capsule2024-02-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Temazepam Capsules USP CIV Rx onlyAphena Pharma Solutions - Tennessee, LLC2024-06-18HUMAN PRESCRIPTION DRUG LABEL4