Bupropion Hydrochloride

Product NDC
71610-131
11-digit product format
716100131
Labeler code
71610
Product ID
71610-131_361b9609-d880-4368-a889-6cfdc6b744b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077285
Marketing category
ANDA
Marketing start
2014-06-24
Marketing end
0000-00-00
Substance
BUPROPION HYDROCHLORIDE
Active strength
300 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
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
71610-131-30Bupropion Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE301
71610-131-60Bupropion Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-131-30EA - Each71610-131a82bb274-fc79-420c-b785-26b0c910889212018-11-06
71610-131-60EA - Each71610-131368c7c0a-3881-4c0f-ab17-1e605a7fd59d12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-131BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20180925_5fe9398a-69be-413d-8147-12a8dfd2bb92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN5fe9398a-69be-413d-8147-12a8dfd2bb921
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD5fe9398a-69be-413d-8147-12a8dfd2bb921
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY5fe9398a-69be-413d-8147-12a8dfd2bb921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71610-131-307161001313030 in 1 BOTTLEHistorical
71610-131-607161001316090 in 1 BOTTLEHistorical