DORAL

Product NDC
61825-165
11-digit product format
618250165
Labeler code
61825
Product ID
61825-165_f188f06d-0e1e-21c0-e053-2a95a90a7ffc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quazepam
Dosage form
TABLET
Route
ORAL
Labeler
Galt Pharmaceuticals, LLC
Application
NDA018708
Marketing category
NDA
Marketing start
2017-07-19
Marketing end
0000-00-00
Substance
QUAZEPAM
Active strength
15 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2024-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61825-165-10EA - Each61825-165b8a979c0-ea86-4550-881f-d00920768e0912016-05-16
61825-165-30EA - Each61825-165ef93c22f-714a-4e23-bb59-3193555df0e912019-11-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61825-165-1061825016510100 TABLET in 1 BOTTLE (61825-165-10) 100 tablet2017-07-190000-00-00NoNoCurrent
61825-165-306182501653030 TABLET in 1 BOTTLE (61825-165-30) 30 tablet2018-12-040000-00-00NoNoCurrent