BUPROPION HYDROCHLORIDE

Product NDC
61919-038
11-digit product format
619190038
Labeler code
61919
Product ID
61919-038_94e04b33-dff1-3364-e053-2a95a90aba21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078866
Marketing category
ANDA
Marketing start
2014-01-01
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-038-302023-01-30C16284748780-1f386c64a-4277-0266-e053-dadaa90a7c1aBUPROPION HYDROCHLORIDE
61919-038-722023-01-30C16284748780-1f386c64a-4277-0266-e053-dadaa90a7c1aBUPROPION HYDROCHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-038-30BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
61919-038-60BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603
61919-038-72BUPROPION HYDROCHLORIDE120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-038-30EA - Each61919-0388659e1dd-7584-42bd-ac52-8c1c67c3c7ce12014-12-01

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-038BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX]3Legacy NDC, 3 package rows20191015_1b69c253-4740-44b0-be63-6c20834540b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN1b69c253-4740-44b0-be63-6c20834540b63
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD1b69c253-4740-44b0-be63-6c20834540b63
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY1b69c253-4740-44b0-be63-6c20834540b63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-038-306191900383030 BOTTLE in 1 BOTTLE (61919-038-30) > 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-038-60) 30 bottle2015-01-010000-00-00NoNoCurrent
61919-038-606191900386060 in 1 BOTTLEHistorical
61919-038-7261919003872120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-038-72) 2014-01-010000-00-00NoNoCurrent