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Roxicet

ROXICET™ CII Oxycodone 5 mg and Acetaminophen 325 mg Tablets, USP Oxycodone 5 mg and Acetaminophen 325 mg Oral Solution per 5 mL

Approved
Approval ID

86817b05-450c-4af0-aeea-acba2ac00601

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 12, 2016

Manufacturers
FDA

West-Ward Pharmaceuticals Corp

DUNS: 080189610

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Oxycodone and Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0054-3686
Application NumberANDA089351
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2016
FDA Product Classification

INGREDIENTS (11)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 5 mL
Code: 362O9ITL9D
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: C1ENJ2TE6C
Classification: ACTIB
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT

Oxycodone and Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0054-8650
Application NumberANDA087003
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2016
FDA Product Classification

INGREDIENTS (6)

STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

Oxycodone and Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0054-8648
Application NumberANDA089351
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2016
FDA Product Classification

INGREDIENTS (11)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
FRUCTOSEInactive
Code: 6YSS42VSEV
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: C1ENJ2TE6C
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 5 mL
Code: 362O9ITL9D
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT

Oxycodone and Acetaminophen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0054-4650
Application NumberANDA087003
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oxycodone and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateAugust 12, 2016
FDA Product Classification

INGREDIENTS (6)

ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
OXYCODONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: C1ENJ2TE6C
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

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Roxicet - FDA Drug Approval Details