buPROpion Hydrochloride

Product NDC
52817-345
11-digit product format
528170345
Labeler code
52817
Product ID
52817-345_f0d4825a-95dd-48f8-e053-2a95a90aeeb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
TruPharma LLC
Application
ANDA211200
Marketing category
ANDA
Marketing start
2022-01-26
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
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
52817-345-50EA - Each52817-345a1ab7a7c-67f1-41b2-9c28-2dc25e09193d12022-02-07
52817-345-90EA - Each52817-3454c9cbba6-b3d1-4f1d-9ea9-c601aa240eda12022-02-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-345-305281703453030 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-345-30) 2022-01-270000-00-00NoNoCurrent
52817-345-5052817034550500 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-345-50) 2022-01-270000-00-00NoNoCurrent
52817-345-905281703459090 TABLET, EXTENDED RELEASE in 1 BOTTLE (52817-345-90) 2022-01-270000-00-00NoNoCurrent