FDA.reportPublic FDA data

BUPROPION HYDROCHLORIDE

Product NDC
43063-744
11-digit product format
430630744
Labeler code
43063
Product ID
43063-744_414b455c-af7f-0fa9-e063-6294a90ac1af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA206674
Marketing category
ANDA
Marketing start
2016-07-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE
Brand name suffix
SR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993518

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-744-30BUPROPION HYDROCHLORIDESR30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-744-30EA - Each43063-7445a3f6e6e-829f-4099-b914-081d6f1917b612017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-744BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PD-RX PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 1 package rows20241016_f5d774dd-0f51-4a4f-a9d1-8b5f2364b1f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSNf5d774dd-0f51-4a4f-a9d1-8b5f2364b1f712
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDf5d774dd-0f51-4a4f-a9d1-8b5f2364b1f712
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSYf5d774dd-0f51-4a4f-a9d1-8b5f2364b1f712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-744-304306307443030 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43063-744-30) 2017-02-090000-00-00NoNoCurrent