FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
82868-019
11-digit product format
828680019
Labeler code
82868
Product ID
82868-019_48352058-8689-4fd6-e063-6394a90aa200
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA205794
Marketing category
ANDA
Marketing start
2023-10-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
SR
Listing expiration
2027-12-31

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
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
82868-019-30Bupropion HydrochlorideSR30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE306
82868-019-60Bupropion HydrochlorideSR60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE606
82868-019-90Bupropion HydrochlorideSR90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE906
82868-019-96Bupropion HydrochlorideSR180 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE1806

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82868-019BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]5Current NDC, 4 package rows20250228_0865f8cf-1d7f-0e67-e063-6294a90a2f4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN0865f8cf-1d7f-0e67-e063-6294a90a2f4d6
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD0865f8cf-1d7f-0e67-e063-6294a90a2f4d6
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY0865f8cf-1d7f-0e67-e063-6294a90a2f4d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82868-019-308286800193030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-019-30) 2024-03-14NoNoHistorical
82868-019-608286800196060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-019-60) 2023-10-19NoNoHistorical
82868-019-908286800199090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-019-90) 2025-01-02NoNoHistorical
82868-019-9682868001996180 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (82868-019-96) 2024-02-19NoNoHistorical