FDA.reportPublic FDA data

BUPROPION HCL ER

Product NDC
61919-674
11-digit product format
619190674
Labeler code
61919
Product ID
61919-674_8e837d14-94d4-1ef9-e053-2995a90a7707
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HCL ER
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA207224
Marketing category
ANDA
Marketing start
2019-07-25
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
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
61919-674-302023-01-30C16284748780-1f386c64a-03a6-0266-e053-dadaa90a7c1aBUPROPION HCL ER (XL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-674-30BUPROPION HCL ERXL30 in 1 BOTTLETABLET, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-674-30EA - Each61919-674e5fa5edc-a300-4c51-a558-a01d03e782a512019-10-07
61919-674-60EA - Each61919-674ef869bff-6001-47ad-861a-f09274b2f78a12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-674BUPROPION HCL ER XL (BUPROPION HCL ER) TABLET, EXTENDED RELEASE [DIRECT_RX]1Legacy NDC, 1 package rows20190909_8e837d14-94d3-1ef9-e053-2995a90a7707.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN8e837d14-94d3-1ef9-e053-2995a90a77071
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD8e837d14-94d3-1ef9-e053-2995a90a77071
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY8e837d14-94d3-1ef9-e053-2995a90a77071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-674-306191906743030 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-674-30) 2019-07-250000-00-00NoNoCurrent