FDA.reportPublic FDA data

Bupropion hydrochloride

Product NDC
70518-4189
11-digit product format
705184189
Labeler code
70518
Product ID
70518-4189_3ff2feab-69af-b316-e063-6294a90a6509
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA215568
Marketing category
ANDA
Marketing start
2024-09-26
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
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 HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541

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
70518-4189-0Bupropion hydrochloride30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4189BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]1Current NDC, 1 package rows20240927_c60855ca-4fa0-4004-ad19-4abb61100c43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNc60855ca-4fa0-4004-ad19-4abb61100c432
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDc60855ca-4fa0-4004-ad19-4abb61100c432
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYc60855ca-4fa0-4004-ad19-4abb61100c432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4189-07051841890030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4189-0) 2024-09-26NoNoCurrent