FDA.reportPublic FDA data

Temazepam

Product NDC
67544-217
11-digit product format
675440217
Labeler code
67544
Product ID
67544-217_1a324c16-932a-45cd-9cb6-0fbe929ae3f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA070920
Marketing category
ANDA
Marketing start
2012-10-25
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
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
67544-217-10EA - Each67544-2172fbf3e3b-866d-4b84-89a5-14250950af8912014-07-02
67544-217-14EA - Each67544-217ee45f059-3c0e-4cb2-b61b-730a2e7bb07812014-07-02
67544-217-15EA - Each67544-2179e8f5f34-4bc4-444d-9b7b-2b05b3b8f7ce12014-07-02
67544-217-20EA - Each67544-217c898e506-cf1e-47f3-8f2b-241ef2c05d4112014-07-02
67544-217-28EA - Each67544-2174028f19b-6c04-4e56-9ddf-28ed94ed1aee12018-01-12
67544-217-30EA - Each67544-217d77456a8-a57d-4ab6-8821-bce8427527a412014-07-02
67544-217-45EA - Each67544-217de43566a-f616-4fe9-9551-4cc4fb94070412014-07-02
67544-217-53EA - Each67544-21750d7fe81-a15a-447d-afac-892de995369312014-07-02
67544-217-60EA - Each67544-21739eda948-13b7-4401-ae4b-e7868855686a12014-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67544-217-106754402171010 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-10) 10 capsule2017-01-260000-00-00NoNoCurrent
67544-217-146754402171414 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-14) 14 capsule2017-09-140000-00-00NoNoCurrent
67544-217-156754402171515 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-15) 15 capsule2015-06-290000-00-00NoNoCurrent
67544-217-206754402172020 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-20) 20 capsule2015-06-140000-00-00NoNoCurrent
67544-217-286754402172828 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-28) 28 capsule2017-02-160000-00-00NoNoCurrent
67544-217-306754402173030 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-30) 30 capsule2013-09-280000-00-00NoNoCurrent
67544-217-456754402174545 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-45) 45 capsule2016-02-090000-00-00NoNoCurrent
67544-217-536754402175360 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-53) 60 capsule2013-09-280000-00-00NoNoCurrent
67544-217-606754402176090 CAPSULE in 1 BOTTLE, PLASTIC (67544-217-60) 90 capsule2013-09-280000-00-00NoNoCurrent