FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
0185-0415
11-digit product format
001850415
Labeler code
0185
Product ID
0185-0415_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
2004-03-22
Marketing end
2025-07-31
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
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
0185-0415-01EA - Each0185-0415489ef6e8-b40c-4126-9227-b2b6f6a0041a12012-07-24
0185-0415-05EA - Each0185-0415881d1177-8502-4e16-a46b-e0ae5b7c7c6a12012-07-24
0185-0415-52EA - Each0185-041544279ce3-d656-4444-9a64-5340646c674c12012-07-24
0185-0415-60EA - Each0185-041504e5c7ec-dae3-474e-88c0-b9473be1e27912012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0415BUPROPION 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
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN9d28d886-676e-4ae2-b4c0-eba9b446117711
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD9d28d886-676e-4ae2-b4c0-eba9b446117711
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY9d28d886-676e-4ae2-b4c0-eba9b446117711
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN54874d2d-2b13-20d9-e054-00144ff8d46c7
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD54874d2d-2b13-20d9-e054-00144ff8d46c7
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY54874d2d-2b13-20d9-e054-00144ff8d46c7
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN5036aa56-e21a-4971-a399-057a77377f4c2
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN8cf8931a-0891-4adb-aeb6-1c91ed9b7de12
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
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD8cf8931a-0891-4adb-aeb6-1c91ed9b7de12
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
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY5036aa56-e21a-4971-a399-057a77377f4c2
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY8cf8931a-0891-4adb-aeb6-1c91ed9b7de12
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY5036aa56-e21a-4971-a399-057a77377f4c2
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN598b0776-3cfc-3044-e053-2a91aa0a6b8d1
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN48a7e42b-9360-4ec6-e054-00144ff88e881
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD598b0776-3cfc-3044-e053-2a91aa0a6b8d1
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD48a7e42b-9360-4ec6-e054-00144ff88e881
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY48a7e42b-9360-4ec6-e054-00144ff88e881
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY598b0776-3cfc-3044-e053-2a91aa0a6b8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0185-0415-0100185041501100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0415-01) 2004-03-222025-07-31NoNoCurrent
0185-0415-0500185041505500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0415-05) 2004-03-222025-04-30NoNoCurrent
0185-0415-5200185041552250 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0415-52) 2004-03-222024-09-30NoNoCurrent
0185-0415-600018504156060 TABLET, EXTENDED RELEASE in 1 BOTTLE (0185-0415-60) 2004-03-222024-09-30NoNoCurrent