FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
70518-2458
11-digit product format
705182458
Labeler code
70518
Product ID
70518-2458_4f95b6cc-0478-391a-e063-6294a90a4885
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210497
Marketing category
ANDA
Marketing start
2019-11-29
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
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
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
70518-2458-0BUPROPION HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9022
70518-2458-1BUPROPION HYDROCHLORIDE360 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE36022
70518-2458-2BUPROPION HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3022
70518-2458-3BUPROPION HYDROCHLORIDE60 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE6022
70518-2458-4BUPROPION HYDROCHLORIDE30 in 1 BOXTABLET, EXTENDED RELEASE3022
70518-2458-5BUPROPION HYDROCHLORIDE1 in 1 POUCHTABLET, EXTENDED RELEASE122
70518-2458-6BUPROPION HYDROCHLORIDE30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3022
70518-2458-7BUPROPION HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE3022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2458-0EA - Each70518-24589a721d9c-dc4f-428b-b441-bdcca6826a4812026-01-08
70518-2458-2EA - Each70518-245849291833-da82-48c7-b3dd-ba988cbf974712026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2458BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 8 package rows20250417_080853c0-fcab-4645-9ddc-4946e895ac5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN080853c0-fcab-4645-9ddc-4946e895ac5f22
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD080853c0-fcab-4645-9ddc-4946e895ac5f22
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY080853c0-fcab-4645-9ddc-4946e895ac5f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2458-07051824580090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2458-0) 2019-11-290000-00-00NoNoCurrent
70518-2458-170518245801360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2458-1) 2019-12-160000-00-00NoNoCurrent
70518-2458-27051824580230 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2458-2) 2020-07-060000-00-00NoNoCurrent
70518-2458-37051824580360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2458-3) 2021-02-190000-00-00NoNoCurrent
70518-2458-47051824580430 in 1 BOXHistorical
70518-2458-5705182458051 in 1 POUCHHistorical
70518-2458-67051824580630 in 1 BOTTLE, PLASTICHistorical
70518-2458-77051824580730 in 1 BLISTER PACKHistorical