FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
45865-885
11-digit product format
458650885
Labeler code
45865
Product ID
45865-885_7dc7c367-1d6a-7634-e053-2a91aa0a9cb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA079095
Marketing category
ANDA
Marketing start
2009-07-02
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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
2019-12-31
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
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
45865-885-302020-01-31C16284748780-19d75b9d0-a120-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR) safely and effectively. See full prescribing information for BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS (SR). BUPROPION HYDROCHLORIDE extended-release tablets (SR), for oral use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-885-30Bupropion HydrochlorideSR30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-885BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20181225_7dc7c367-1d69-7634-e053-2a91aa0a9cb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN7dc7c367-1d69-7634-e053-2a91aa0a9cb92
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD7dc7c367-1d69-7634-e053-2a91aa0a9cb92
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY7dc7c367-1d69-7634-e053-2a91aa0a9cb92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-885-304586508853030 in 1 BOTTLE, PLASTICHistorical