BUPROPION HYDROCHLORIDE

Product NDC
50090-5163
11-digit product format
500905163
Labeler code
50090
Product ID
50090-5163_6f3ebf11-0131-4add-860d-3c3fe243d5ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA210497
Marketing category
ANDA
Marketing start
2018-11-08
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5163-05009051630090 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5163-0) 2020-09-230000-00-00NoNoCurrent
50090-5163-15009051630130 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5163-1) 2020-09-230000-00-00NoNoCurrent
50090-5163-25009051630260 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5163-2) 2020-09-230000-00-00NoNoCurrent