Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PAXILCR CR
Product Details
NDC Product Code
54868-5365Application Number
NDA020936Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 8, 2011ParoxetineActive
Code: 3I3T11UD2SClass: ACTIBQuantity: 37.5 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
PAXILCR CR
Product Details
NDC Product Code
54868-4791Application Number
NDA020936Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 8, 2011ParoxetineActive
Code: 3I3T11UD2SClass: ACTIBQuantity: 25 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
PAXILCR CR
Product Details
NDC Product Code
54868-5347Application Number
NDA020936Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 8, 2011HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
ParoxetineActive
Code: 3I3T11UD2SClass: ACTIBQuantity: 12.5 mg in 1 1
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
GLYCERYL BEHENATEInactive
Code: R8WTH25YS2Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT