PAXIL
PAXIL (paroxetine hydrochloride) Tablets and Oral Suspension
Approved
Approval ID
40226242-da82-4dd7-bca2-eebb14501264
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2012
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.
paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3526
Application NumberNDA020031
Product Classification
M
Marketing Category
C73594
G
Generic Name
paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2012
FDA Product Classification
INGREDIENTS (7)
PAROXETINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 3I3T11UD2S
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
paroxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2976
Application NumberNDA020031
Product Classification
M
Marketing Category
C73594
G
Generic Name
paroxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2012
FDA Product Classification
INGREDIENTS (7)
PAROXETINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 3I3T11UD2S
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT