Bupropion hydrochloride

Product NDC
63187-178
11-digit product format
631870178
Labeler code
63187
Product ID
63187-178_73572f20-b22c-4c8c-b99e-5eb8e70f9be0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078866
Marketing category
ANDA
Marketing start
2010-04-08
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503, 993518, 993536

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-178-30Bupropion hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
63187-178-60Bupropion hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE605
63187-178-90Bupropion hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-178BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20191008_d4272e3f-78ee-4d80-b911-e840fb14acbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNd4272e3f-78ee-4d80-b911-e840fb14acbe5
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNd4272e3f-78ee-4d80-b911-e840fb14acbe5
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSNd4272e3f-78ee-4d80-b911-e840fb14acbe5
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDd4272e3f-78ee-4d80-b911-e840fb14acbe5
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDd4272e3f-78ee-4d80-b911-e840fb14acbe5
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCDd4272e3f-78ee-4d80-b911-e840fb14acbe5
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYd4272e3f-78ee-4d80-b911-e840fb14acbe5
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYd4272e3f-78ee-4d80-b911-e840fb14acbe5
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSYd4272e3f-78ee-4d80-b911-e840fb14acbe5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-178-306318701783030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-178-30) 2014-05-010000-00-00NoNoCurrent
63187-178-606318701786060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-178-60) 2014-05-010000-00-00NoNoCurrent
63187-178-906318701789090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-178-90) 2014-05-010000-00-00NoNoCurrent