Temazepam

Product NDC
0378-3120
11-digit product format
003783120
Labeler code
0378
Product ID
0378-3120_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
2009-06-15
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
23 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3120-93EA - Each0378-31202eb1e119-e60d-4134-9841-ec745cc27e7212012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3120-930037831209330 CAPSULE in 1 BOTTLE, PLASTIC (0378-3120-93) 30 capsule2009-06-150000-00-00NoNoCurrent