FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
0615-8601
11-digit product format
006158601
Labeler code
0615
Product ID
0615-8601_82d92152-92be-419f-a7a5-7b36b318ea1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA216800
Marketing category
ANDA
Marketing start
2023-05-31
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503, 993518

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
0615-8601-39Bupropion hydrochloride30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY1bd2ed35-35c5-464f-bf51-9dd4b42ee59a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8601-390061586013930 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8601-39) 2025-10-31NoNoCurrent