FDA.reportPublic FDA data

Bupropion Hydrochloride (XL)

Product NDC
83301-0025
11-digit product format
833010025
Labeler code
83301
Product ID
83301-0025_4990307c-8f79-4a7b-e063-6294a90a7b94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Mullan Pharmaceutical Inc.
Application
ANDA208652
Marketing category
ANDA
Marketing start
2024-06-17
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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 (XL)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541, 993557

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
83301-0025-1Bupropion Hydrochloride (XL)30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE305
83301-0025-2Bupropion Hydrochloride (XL)90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE905
83301-0025-3Bupropion Hydrochloride (XL)500 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE5005
83301-0025-4Bupropion Hydrochloride (XL)1000 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0025BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MULLAN PHAMACEUTICAL INC.]2Current NDC, 4 package rows20241017_75b1e027-4c5d-46e5-98ee-033e67bd411c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN75b1e027-4c5d-46e5-98ee-033e67bd411c5
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN75b1e027-4c5d-46e5-98ee-033e67bd411c5
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD75b1e027-4c5d-46e5-98ee-033e67bd411c5
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD75b1e027-4c5d-46e5-98ee-033e67bd411c5
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY75b1e027-4c5d-46e5-98ee-033e67bd411c5
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY75b1e027-4c5d-46e5-98ee-033e67bd411c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83301-0025-18330100250130 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-1) 2024-06-17NoNoCurrent
83301-0025-28330100250290 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-2) 2024-06-17NoNoCurrent
83301-0025-383301002503500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-3) 2024-06-17NoNoCurrent
83301-0025-4833010025041000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (83301-0025-4) 2024-06-17NoNoCurrent