FDA.reportPublic FDA data

Bupropion Hydrochloride

Product NDC
0591-3331
11-digit product format
005913331
Labeler code
0591
Product ID
0591-3331_08ef0752-1fcf-418b-9b72-3fbab8b23058
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupropion Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA077715
Marketing category
ANDA
Marketing start
2008-11-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupropion Hydrochloride
Brand name suffix
XL
Listing expiration
2027-12-31

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
0591-3331-05Bupropion HydrochlorideXL500 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE50039
0591-3331-19Bupropion HydrochlorideXL90 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE9039
0591-3331-30Bupropion HydrochlorideXL30 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE3039

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3331-05EA - Each0591-3331798bf2a9-e323-4d9a-9523-2d22fa28441012012-07-24
0591-3331-19EA - Each0591-333162edb842-536d-412e-a192-96b1c966c1b112012-07-24
0591-3331-30EA - Each0591-333115376217-9d7f-42c5-ba12-79b3d4211aa212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]23
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE EXTENDED RELEASE (XL) (BUPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [DISPENSING SOLUTIONS, INC.]3
BUPROPION HYDROCHLORIDEACTIVE INGREDIENTZG7E5POY8OBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
BUPROPIONACTIVE MOIETY01ZG3TPX31BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ETHYLCELLULOSEINACTIVE INGREDIENT7Z8S9VYZ4BBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3331BUPROPION HYDROCHLORIDE XL (BUPROPION HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]37Current NDC, Legacy NDC, 3 package rows20250422_a1e768fd-c28f-4b49-822d-ccc315b4099c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNa1e768fd-c28f-4b49-822d-ccc315b4099c39
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDa1e768fd-c28f-4b49-822d-ccc315b4099c39
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYa1e768fd-c28f-4b49-822d-ccc315b4099c39
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNec9cbb38-1582-492f-a526-4b3675c55b145
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN82f5292b-b113-4f10-9469-04386fa8e9d45
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN7562d7e7-4dc3-44dc-a174-c0613feb3d6b5
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN82f5292b-b113-4f10-9469-04386fa8e9d45
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDec9cbb38-1582-492f-a526-4b3675c55b145
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD82f5292b-b113-4f10-9469-04386fa8e9d45
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD7562d7e7-4dc3-44dc-a174-c0613feb3d6b5
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD82f5292b-b113-4f10-9469-04386fa8e9d45
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYec9cbb38-1582-492f-a526-4b3675c55b145
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY7562d7e7-4dc3-44dc-a174-c0613feb3d6b5
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY82f5292b-b113-4f10-9469-04386fa8e9d45
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY82f5292b-b113-4f10-9469-04386fa8e9d45
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b4
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b4
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY9d08b4ae-077d-4cd8-9ca4-8d5cd63f400b4
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN23de55c2-c695-469e-9541-c377a8cef5c33
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN23de55c2-c695-469e-9541-c377a8cef5c33
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD23de55c2-c695-469e-9541-c377a8cef5c33
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD23de55c2-c695-469e-9541-c377a8cef5c33
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY23de55c2-c695-469e-9541-c377a8cef5c33
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY23de55c2-c695-469e-9541-c377a8cef5c33
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNd1d0872c-5b11-4e13-a401-b122348e0fa72
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDd1d0872c-5b11-4e13-a401-b122348e0fa72
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYd1d0872c-5b11-4e13-a401-b122348e0fa72
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSN22009d23-999c-4fa6-bfe7-21395f5772361
993541buPROPion HCl 150 MG 24HR Extended Release Oral TabletPSNaf94e1a9-fb47-4842-8cde-5b5f44fb83cd1
993557buPROPion HCl 300 MG 24HR Extended Release Oral TabletPSN22009d23-999c-4fa6-bfe7-21395f5772361
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCDaf94e1a9-fb47-4842-8cde-5b5f44fb83cd1
99354124 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD22009d23-999c-4fa6-bfe7-21395f5772361
99355724 HR bupropion hydrochloride 300 MG Extended Release Oral TabletSCD22009d23-999c-4fa6-bfe7-21395f5772361
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSY22009d23-999c-4fa6-bfe7-21395f5772361
993541bupropion HCl XL 150 MG 24 HR Extended Release Oral TabletSYaf94e1a9-fb47-4842-8cde-5b5f44fb83cd1
993557bupropion HCl XL 300 MG 24 HR Extended Release Oral TabletSY22009d23-999c-4fa6-bfe7-21395f5772361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3331-0500591333105500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-05) 2008-11-260000-00-00NoNoCurrent
0591-3331-190059133311990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-19) 2008-11-260000-00-00NoNoCurrent
0591-3331-300059133313030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3331-30) 2008-11-260000-00-00NoNoCurrent