FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
0115-5445
11-digit product format
001155445
Labeler code
0115
Product ID
0115-5445_cb660c34-cfd0-4598-a767-db8a82e087e0
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
ANDA076711
Marketing category
ANDA
Marketing start
2004-12-03
Substance
BUPROPION HYDROCHLORIDE
Active strength
200 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 HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993536

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
0115-5445-13Bupropion Hydrochloride60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE6027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-5445-13EA - Each0115-5445d261bb47-2bbe-4e2c-ab25-47b1322b5a2212012-07-24

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.]6
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6
TRIACETININACTIVE INGREDIENTXHX3C3X673BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-5445BUPROPION HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]27Current NDC, Legacy NDC, 1 package rows20240517_e962fb9a-d9fb-49c5-a8b4-0b355b8f829b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSNe962fb9a-d9fb-49c5-a8b4-0b355b8f829b27
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCDe962fb9a-d9fb-49c5-a8b4-0b355b8f829b27
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSYe962fb9a-d9fb-49c5-a8b4-0b355b8f829b27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0115-5445-130011554451360 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-5445-13) 2004-12-030000-00-00NoNoCurrent