Bupropion hydrochloride (XL)

Product NDC
71205-045
11-digit product format
712050045
Labeler code
71205
Product ID
71205-045_0733a90a-9dbf-4cf2-a3b7-3b2dcdc5fbc5
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
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
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
71205-045-30EA - Each71205-0456cfa1f61-3701-44a7-b6f0-aa6786d8226012018-08-13
71205-045-90EA - Each71205-045367b37aa-a673-4770-b035-74d5c279647012019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-045BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]3Legacy NDC20191030_8d62dcc5-9a5d-4d95-bd47-d7535c03ff56.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-045-307120500453030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-045-30) 2018-06-010000-00-00NoNoCurrent
71205-045-607120500456060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-045-60) 2018-06-010000-00-00NoNoCurrent
71205-045-907120500459090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-045-90) 2018-06-010000-00-00NoNoCurrent