Bupropion hydrochloride (XL)

Product NDC
71205-248
11-digit product format
712050248
Labeler code
71205
Product ID
71205-248_a92e4484-0bf2-4390-8cb6-f7f2412206e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA208652
Marketing category
ANDA
Marketing start
2018-01-08
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
71205-248-30EA - Each71205-24812ac0a7e-381b-42a4-bab4-3961f0be011112019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-248BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]3Legacy NDC20200121_800cbfb1-fa7c-4395-97a8-b02a2256a93d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-248-307120502483030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-248-30) 2019-04-010000-00-00NoNoCurrent
71205-248-607120502486060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-248-60) 2019-04-010000-00-00NoNoCurrent
71205-248-907120502489090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-248-90) 2019-04-010000-00-00NoNoCurrent