Bupropion Hydrochloride

Product NDC: 0378-0435
11-digit product format: 003780435
Labeler code: 0378
Product ID: 0378-0435_272aa2fb-718c-48bf-ab6a-a39baaf28fed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bupropion hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA075491
Marketing category: ANDA
Marketing start: 2000-05-11
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4eceb285-f3c7-4092-a21a-4c9f3169f20c	Product name	5	20260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8	Product name	3	20240209
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
b8ee525f-67fb-39fb-91da-7e47ac54581d	Product name	5	20200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284	Product name	9	20190211
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
0916dcfb-331f-89b1-8eac-6f7dc76d82da	Product name	1	20140508
d7fc3d53-5a6c-de82-2808-1780f175f17e	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0435-01	EA - Each	0378-0435	ba01ba8e-ebb0-4d44-b3d2-1b5dc3d67510	1	2012-07-24
0378-0435-05	EA - Each	0378-0435	339652fe-7675-4227-b921-90bd7ed60289	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
BUPROPION HYDROCHLORIDE	ACTIVE INGREDIENT	ZG7E5POY8O	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
BUPROPION	ACTIVE MOIETY	01ZG3TPX31	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	BUPROPION HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ZG7E5POY8O	BUPROPION HYDROCHLORIDE	31677-93-7	BUPROPION HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
993687	buPROPion HCl 100 MG Oral Tablet	PSN	28fa8921-7546-4681-89ab-9ec32695e701	2
993691	buPROPion HCl 75 MG Oral Tablet	PSN	28fa8921-7546-4681-89ab-9ec32695e701	2
993687	bupropion hydrochloride 100 MG Oral Tablet	SCD	28fa8921-7546-4681-89ab-9ec32695e701	2
993691	bupropion hydrochloride 75 MG Oral Tablet	SCD	28fa8921-7546-4681-89ab-9ec32695e701	2
993691	bupropion HCl 75 MG Oral Tablet	SY	28fa8921-7546-4681-89ab-9ec32695e701	2
993687	buPROPion HCl 100 MG Oral Tablet	PSN	9ac9a12c-25a1-4547-8a79-a79f83854dc5	1
993687	buPROPion HCl 100 MG Oral Tablet	PSN	d06963c7-f6de-484e-a212-34d865939e8e	1
993687	buPROPion HCl 100 MG Oral Tablet	PSN	e2eaf21d-0589-484e-9dba-82b3cd2299ac	1
993691	buPROPion HCl 75 MG Oral Tablet	PSN	9ac9a12c-25a1-4547-8a79-a79f83854dc5	1
993687	bupropion hydrochloride 100 MG Oral Tablet	SCD	9ac9a12c-25a1-4547-8a79-a79f83854dc5	1
993687	bupropion hydrochloride 100 MG Oral Tablet	SCD	d06963c7-f6de-484e-a212-34d865939e8e	1
993687	bupropion hydrochloride 100 MG Oral Tablet	SCD	e2eaf21d-0589-484e-9dba-82b3cd2299ac	1
993691	bupropion hydrochloride 75 MG Oral Tablet	SCD	9ac9a12c-25a1-4547-8a79-a79f83854dc5	1
993691	bupropion HCl 75 MG Oral Tablet	SY	9ac9a12c-25a1-4547-8a79-a79f83854dc5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0435-01	00378043501	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0435-01)	2000-05-11	0000-00-00	No	No	Current
0378-0435-05	00378043505	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0435-05)	2010-03-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BUPROPION - H.J. Harkins Company, Inc. \| Mylan Pharmaceuticals Inc.	H.J. Harkins Company, Inc. \| Mylan Pharmaceuticals Inc.	2011-08-29	HUMAN PRESCRIPTION DRUG LABEL	1
Bupropion Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-05-06	HUMAN PRESCRIPTION DRUG LABEL	2
Bupropion Hydrochloride - State of Florida DOH Central Pharmacy	State of Florida DOH Central Pharmacy	2010-03-29	HUMAN PRESCRIPTION DRUG LABEL	1
Bupropion Hydrochloride - Contract Pharmacy Services-PA	Contract Pharmacy Services-PA	2010-02-24	HUMAN PRESCRIPTION DRUG LABEL	1

Bupropion Hydrochloride

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#