FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
70518-4081
11-digit product format
705184081
Labeler code
70518
Product ID
70518-4081_4c99c0d5-3b4e-de4b-e063-6294a90a822c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA216800
Marketing category
ANDA
Marketing start
2024-05-16
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
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
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
70518-4081-0Bupropion hydrochloride180 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE1805
70518-4081-1Bupropion hydrochloride30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE305
70518-4081-2Bupropion hydrochloride60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE605
70518-4081-3Bupropion hydrochloride90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE905
70518-4081-4Bupropion hydrochloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4081BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]2Current NDC, 5 package rows20250116_6087100f-3ba4-412e-b08d-768d1dcdaf00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN6087100f-3ba4-412e-b08d-768d1dcdaf005
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD6087100f-3ba4-412e-b08d-768d1dcdaf005
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY6087100f-3ba4-412e-b08d-768d1dcdaf005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4081-070518408100180 in 1 BOTTLE, PLASTICHistorical
70518-4081-17051840810130 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4081-1) 2024-09-26NoNoHistorical
70518-4081-27051840810260 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-2) 2025-07-01NoNoHistorical
70518-4081-37051840810390 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-3) 2025-07-01NoNoHistorical
70518-4081-47051840810430 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4081-4) 2025-08-27NoNoHistorical