FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
0185-0410
11-digit product format
001850410
Labeler code
0185
Product ID
0185-0410_93be4c14-9bab-40e5-884b-5d3cb377210f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA075932
Marketing category
ANDA
Marketing start
2003-11-25
Marketing end
2025-07-31
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 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
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0410-01EA - Each0185-041093c09969-73e9-411d-b3ab-c413be1025c712012-07-24
0185-0410-05EA - Each0185-04108a59899f-65c9-408c-9f9e-0c48d20c193912012-07-24
0185-0410-60EA - Each0185-04100b172dca-cdbe-4839-9a49-017bbca68c1f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]21
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE SR (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0410BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EON LABS, INC.]28Legacy NDC20220513_165475dd-a250-48bb-b4c8-65c189194a9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN5036aa56-e21a-4971-a399-057a77377f4c2
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSNf7364c33-09f8-4113-8cdb-fb8f2aec71de2
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN5036aa56-e21a-4971-a399-057a77377f4c2
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN5036aa56-e21a-4971-a399-057a77377f4c2
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD5036aa56-e21a-4971-a399-057a77377f4c2
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCDf7364c33-09f8-4113-8cdb-fb8f2aec71de2
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD5036aa56-e21a-4971-a399-057a77377f4c2
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD5036aa56-e21a-4971-a399-057a77377f4c2
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY5036aa56-e21a-4971-a399-057a77377f4c2
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSYf7364c33-09f8-4113-8cdb-fb8f2aec71de2
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY5036aa56-e21a-4971-a399-057a77377f4c2
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY5036aa56-e21a-4971-a399-057a77377f4c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-0410-0100185041001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0410-01) 2003-11-252025-05-31NoNoCurrent
0185-0410-0500185041005500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0410-05) 2003-11-252024-09-30NoNoCurrent
0185-0410-5200185041052250 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0410-52) 2003-11-250000-00-00NoNoCurrent
0185-0410-600018504106060 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0410-60) 2003-11-252025-05-31NoNoCurrent