Temazepam

Product NDC
0378-3110
11-digit product format
003783110
Labeler code
0378
Product ID
0378-3110_57e251a0-cc54-4ae9-818d-a2f168e3fb13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA070920
Marketing category
ANDA
Marketing start
2010-05-18
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
8 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198243temazepam 7.5 MG Oral CapsulePSN4ac590e9-af71-43c0-a836-b700115d7ba22
198243temazepam 7.5 MG Oral CapsuleSCD4ac590e9-af71-43c0-a836-b700115d7ba22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3110-0100378311001100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3110-01) 100 capsule2010-05-180000-00-00NoNoCurrent