Bupropion
Approved
Approval ID
82f5292b-b113-4f10-9469-04386fa8e9d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bupropion hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5927
Application NumberANDA077715
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2010
FDA Product Classification
INGREDIENTS (1)
BUPROPION HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
bupropion hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5736
Application NumberANDA077715
Product Classification
M
Marketing Category
C73584
G
Generic Name
bupropion hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2010
FDA Product Classification
INGREDIENTS (11)
BUPROPION HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: ZG7E5POY8O
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSEInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT