Bupropion Hydrochloride

Product NDC
67046-081
11-digit product format
670460081
Labeler code
67046
Product ID
67046-081_597a1ea2-7f77-1d9a-e053-2991aa0a94b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupropion hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA206556
Marketing category
ANDA
Marketing start
2016-08-29
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-081-30Bupropion Hydrochloride(XL)30 in 1 BLISTER PACKTABLET, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-081BUPROPION HYDROCHLORIDE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20170918_597a29c0-b1b2-497b-e053-2a91aa0ad2ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN597a29c0-b1b2-497b-e053-2a91aa0ad2ba1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD597a29c0-b1b2-497b-e053-2a91aa0ad2ba1
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY597a29c0-b1b2-497b-e053-2a91aa0ad2ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-081-306704600813030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-081-30) 2017-09-180000-00-00NoNoCurrent