FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
70518-3963
11-digit product format
705183963
Labeler code
70518
Product ID
70518-3963_5110fa79-424e-13b9-e063-6294a90a293d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207479
Marketing category
ANDA
Marketing start
2023-12-14
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
(XL)
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
70518-3963-0Bupropion Hydrochloride(XL)30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE306
70518-3963-1Bupropion Hydrochloride(XL)60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE606
70518-3963-2Bupropion Hydrochloride(XL)90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE906
70518-3963-3Bupropion Hydrochloride(XL)30 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE306
70518-3963-4Bupropion Hydrochloride(XL)30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3963BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REMEDYREPACK INC.]3Current NDC, 5 package rows20240405_0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c46
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c46
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY0cd6e0e2-6b2c-4e0d-b5b2-ebfe0d5e31c46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3963-07051839630030 in 1 BOTTLE, PLASTICHistorical
70518-3963-17051839630160 in 1 BOTTLE, PLASTICHistorical
70518-3963-27051839630290 in 1 BOTTLE, PLASTICHistorical
70518-3963-37051839630330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70518-3963-3) 2024-01-19NoNoCurrent
70518-3963-47051839630430 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3963-4) 2026-05-04NoNoCurrent