FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
45865-975
11-digit product format
458650975
Labeler code
45865
Product ID
45865-975_9af0fadd-0efa-2317-e053-2a95a90a9a88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA210497
Marketing category
ANDA
Marketing start
2018-11-08
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-975-302025-01-30C16284748780-12cef2736-a453-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985
45865-975-602025-01-30C16284748780-12cef2736-a453-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (XL). BUPROPION HYDROCHLORIDE extended-release tablets (XL), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-975-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE301
45865-975-60BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-975BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20191231_9af0fadd-0ef9-2317-e053-2a95a90a9a88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN9af0fadd-0ef9-2317-e053-2a95a90a9a881
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD9af0fadd-0ef9-2317-e053-2a95a90a9a881
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY9af0fadd-0ef9-2317-e053-2a95a90a9a881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-975-304586509753030 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-975-30) 2019-12-110000-00-00NoNoCurrent
45865-975-604586509756060 TABLET, EXTENDED RELEASE in 1 BOTTLE (45865-975-60) 2019-12-110000-00-00NoNoCurrent