Bupropion Hydrochloride

Product NDC
64679-103
11-digit product format
646790103
Labeler code
64679
Product ID
64679-103_f0f5ceaa-d325-5948-e053-2a95a90a94e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA202189
Marketing category
ANDA
Marketing start
2022-01-28
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64679-103-016467901030130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-103-01) 2022-01-280000-00-00NoNoCurrent
64679-103-026467901030290 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-103-02) 2022-01-280000-00-00NoNoCurrent
64679-103-0564679010305500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (64679-103-05) 2022-01-280000-00-00NoNoCurrent