Bupropion hydrochloride (XL)

Product NDC
68788-7347
11-digit product format
687887347
Labeler code
68788
Product ID
68788-7347_38f9d8ff-18c1-4779-88d3-62df2b461d20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA208652
Marketing category
ANDA
Marketing start
2019-03-08
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7347-1EA - Each68788-7347d3fd6037-3287-4829-994d-5b968aa13a8512019-05-02
68788-7347-3EA - Each68788-73475581cfcb-befe-4448-865d-84cea68e9c8212019-05-02
68788-7347-6EA - Each68788-7347b8efb1ea-f584-4dc7-b2ce-2380b40b7ba212019-05-02
68788-7347-8EA - Each68788-7347e715b719-0f84-48b7-9b0f-c8039242f9f412019-05-02
68788-7347-9EA - Each68788-734774b453be-6570-41dd-b9aa-0b86ad5d91e912019-05-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7347-168788734701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7347-1) 2019-03-080000-00-00NoNoCurrent
68788-7347-36878873470330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7347-3) 2019-03-080000-00-00NoNoCurrent
68788-7347-66878873470660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7347-6) 2019-03-080000-00-00NoNoCurrent
68788-7347-868788734708120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7347-8) 2019-03-080000-00-00NoNoCurrent
68788-7347-96878873470990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7347-9) 2019-03-080000-00-00NoNoCurrent