BUPROPION HYDROCHLORIDE

Product NDC
76519-1021
11-digit product format
765191021
Labeler code
76519
Product ID
76519-1021_5f250748-b4b9-571c-e053-2991aa0ae218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company Inc.
Application
ANDA206556
Marketing category
ANDA
Marketing start
2017-01-03
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
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
76519-1021-32020-01-31C16284748780-19d75b9d0-c65b-f424-e053-dadaa90a57ce5f250748-b4b8-571c-e053-2991aa0ae218
76519-1021-52020-01-31C16284748780-19d75b9d0-c65b-f424-e053-dadaa90a57ce5f250748-b4b8-571c-e053-2991aa0ae218

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1021-3BUPROPION HYDROCHLORIDE30 in 1 CONTAINERTABLET, EXTENDED RELEASE301
76519-1021-5BUPROPION HYDROCHLORIDE150 in 1 CONTAINERTABLET, EXTENDED RELEASE1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1021BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [H.J. HARKINS COMPANY INC.]1Legacy NDC, 2 package rows20171206_5f250748-b4b8-571c-e053-2991aa0ae218.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN5f250748-b4b8-571c-e053-2991aa0ae2181
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD5f250748-b4b8-571c-e053-2991aa0ae2181
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY5f250748-b4b8-571c-e053-2991aa0ae2181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76519-1021-37651910210330 in 1 CONTAINERHistorical
76519-1021-576519102105150 in 1 CONTAINERHistorical