FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
0115-6811
11-digit product format
001156811
Labeler code
0115
Product ID
0115-6811_5fb023e1-b35a-40c0-a5aa-1e383dcd4d86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA077415
Marketing category
ANDA
Marketing start
2009-05-01
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993541

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
0115-6811-02Bupropion Hydrochloride500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50021
0115-6811-08Bupropion Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3021
0115-6811-10Bupropion Hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-6811-02EA - Each0115-68119ee472fe-d92d-494e-9857-7c0fb628aae712012-07-24
0115-6811-08EA - Each0115-681130f45af6-67f3-4369-9a60-d83e3fc0a6c612012-07-24
0115-6811-10EA - Each0115-681160171258-9552-47d5-881e-2818afb9d1cf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES, INC.]3
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-6811BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]21Current NDC, Legacy NDC, 3 package rows20250328_fddc9630-2f9a-4104-888f-3714587d4fe7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNfddc9630-2f9a-4104-888f-3714587d4fe721
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDfddc9630-2f9a-4104-888f-3714587d4fe721
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYfddc9630-2f9a-4104-888f-3714587d4fe721
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNe57451fd-aba5-47d6-9892-ffe2a6021b6f3
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDe57451fd-aba5-47d6-9892-ffe2a6021b6f3
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYe57451fd-aba5-47d6-9892-ffe2a6021b6f3
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN1f7fd914-0978-664e-e054-00144ff88e882
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD1f7fd914-0978-664e-e054-00144ff88e882
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY1f7fd914-0978-664e-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-6811-0200115681102500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-6811-02) 2009-05-010000-00-00NoNoCurrent
0115-6811-080011568110830 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-6811-08) 2009-05-010000-00-00NoNoCurrent
0115-6811-100011568111090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-6811-10) 2009-05-010000-00-00NoNoCurrent