FDA.reportPublic FDA data

bupropion

Product NDC
71205-565
11-digit product format
712050565
Labeler code
71205
Product ID
71205-565_64c33202-1fb1-4e0a-ae72-146375fa81aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202304
Marketing category
ANDA
Marketing start
2014-11-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993518

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-565-30bupropion30 in 1 BOTTLETABLET, EXTENDED RELEASE302
71205-565-60bupropion60 in 1 BOTTLETABLET, EXTENDED RELEASE602
71205-565-90bupropion90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-565-30EA - Each71205-5654eb397ba-a518-42d3-801c-ccc7ec78203612021-10-08
71205-565-60EA - Each71205-565bd461bda-ffd8-466e-b44e-0617d31435a512021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-565BUPROPION (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220413_909204fc-ff55-43d9-b9ee-e607ef60965e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN909204fc-ff55-43d9-b9ee-e607ef60965e2
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD909204fc-ff55-43d9-b9ee-e607ef60965e2
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY909204fc-ff55-43d9-b9ee-e607ef60965e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-565-307120505653030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-565-30) 2021-05-110000-00-00NoNoCurrent
71205-565-607120505656060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-565-60) 2021-05-110000-00-00NoNoCurrent
71205-565-907120505659090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-565-90) 2021-05-110000-00-00NoNoCurrent