FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
42806-424
11-digit product format
428060424
Labeler code
42806
Product ID
42806-424_50036e03-a443-a430-e063-6394a90a72c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA211347
Marketing category
ANDA
Marketing start
2023-09-18
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
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 HYDROCHLORIDE100 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
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
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
42806-424-01Bupropion HydrochlorideSR100 in 1 BOTTLETABLET, EXTENDED RELEASE1007
42806-424-05Bupropion HydrochlorideSR500 in 1 BOTTLETABLET, EXTENDED RELEASE5007
42806-424-60Bupropion HydrochlorideSR60 in 1 BOTTLETABLET, EXTENDED RELEASE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-424-01EA - Each42806-42498629e34-d667-4867-9bf2-a460e2fb5eec12025-01-14
42806-424-60EA - Each42806-424f9d0c59b-1af0-401b-8d73-f74b18b4754212024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-424BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [EPIC PHARMA, LLC]5Current NDC, 3 package rows20241204_f8ad76a2-9f75-4660-973d-34402f314e9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNf8ad76a2-9f75-4660-973d-34402f314e9c7
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNf8ad76a2-9f75-4660-973d-34402f314e9c7
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSNf8ad76a2-9f75-4660-973d-34402f314e9c7
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDf8ad76a2-9f75-4660-973d-34402f314e9c7
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf8ad76a2-9f75-4660-973d-34402f314e9c7
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCDf8ad76a2-9f75-4660-973d-34402f314e9c7
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYf8ad76a2-9f75-4660-973d-34402f314e9c7
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYf8ad76a2-9f75-4660-973d-34402f314e9c7
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSYf8ad76a2-9f75-4660-973d-34402f314e9c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42806-424-0142806042401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-01) 2023-09-18NoNoHistorical
42806-424-0542806042405500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-05) 2023-09-18NoNoHistorical
42806-424-604280604246060 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-424-60) 2023-09-18NoNoHistorical