Temazepam

Product NDC
68788-7163
11-digit product format
687887163
Labeler code
68788
Product ID
68788-7163_0df1d233-7be3-42e1-a7d6-764f4b9f0755
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA071620
Marketing category
ANDA
Marketing start
2018-06-05
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
15 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7163-3EA - Each68788-7163635b09b9-00a0-4048-9076-6b94855777eb12018-08-13
68788-7163-6EA - Each68788-7163104e8fd8-6fa8-44c3-8865-0bdcb1b1dde412018-08-13
68788-7163-9EA - Each68788-7163c3d06910-7085-4770-a50a-32317922c39a12018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7163-068788716300100 CAPSULE in 1 BOTTLE (68788-7163-0) 100 capsule2018-06-050000-00-00NoNoCurrent
68788-7163-36878871630330 CAPSULE in 1 BOTTLE (68788-7163-3) 30 capsule2018-06-050000-00-00NoNoCurrent
68788-7163-66878871630660 CAPSULE in 1 BOTTLE (68788-7163-6) 60 capsule2018-06-050000-00-00NoNoCurrent
68788-7163-96878871630990 CAPSULE in 1 BOTTLE (68788-7163-9) 90 capsule2018-06-050000-00-00NoNoCurrent